Geron can continue to provide a key part of the equation

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huntingonthebluffs
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Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Sun Sep 09, 2018 8:46 pm

Okay, so for me 90+ percent or more of what I worry about doesn’t happen. With that as my guide, I also find that frequently things turn out much better than I expected when the various elements have significant human impacts. So with Imetelstat, I personally see that JS’s Geron has actually performed its mission close to as well as it could, not perfect of course as humans are involved. Progress can be especially noticeable since taking over, if compared to a situation that had gone mostly nowhere out of the company and its lab for decades.
Now given history and events since the license agreement signing with JNJ/Janssen, while I believe JNJ/Janssen has handled the CTs professionally well, most would say far from perfectly and certainly it appears to be in slow motion to many of us. In my mind, the amount of time before and since the hold in 2014 when JNJ/Janssen were visible partners, just two CT’s have been started, over three years have since passed while many thousands of patients untreated with Imetelstat have died and progress has been botched up on a few stumbles that may or may not have been avoided given circumstances we may never understand but not likely due to Geron’s involvement.

Now with orphan drug designation (ODD), fast track designation (FTD), right to try, compassionate use, etc. not able to get this drug to those outside of the CTs in need because of the many doors and loose ends left up to the patient and attending doctor to navigate. So I think in my humble and likely very uneducated opinion, JNJ/Janssen, the FDA/EUA, insurance companies, hospitals, patient support organizations, etc. have had the ball for essentially 4 years and still haven’t scored with what is potentially (probably likely) the most overall effective and widely pervasively cancer drug available today still basically sitting on the shelf.

Now here we stand at the threshold and many want to jettison Geron as unneeded, getting in the way, slowing things down, preventing progress and further successes. So many say, let’s get to the BO quickly and end our frustration and investment pains. But doesn’t Geron still have an important role to play and stands as the most dedicated and supportive Imetelstat proponent. Who knows where JNJ/Janssen and the rest of bureaucratic machinery will take this science given all their other options and interests, which I suspect are not all as honorable as some want us to believe.

Who has Geron’s Imetelstat and the rest of the company’s patent farm and IP most at heart? Maybe JNJ/Janssen, maybe not but certainly mighty little Geron does! While I think those of us wanting a quick fix via a buyout are maybe justified in some ways but I think that wish is really more due to JNJ/Janssen and the bureaucratic process than anything Geron has miss managed. If we had come to the threshold we are not at a year or more ago, would we still all be harping about Geron’s management and all those options, etc.? Mostly not, of course the shorts would keep up their continuous misinformation campaigns regardless.

So do we really want Geron out of the picture or for the good of science, cancer patients and their families and of course our investments do we need that keen focus on the singular cancer weapon of telomerase inhibition? I know what I prefer and it is not a buyout this year and maybe not ever. But I will try to keep an open mind while the music is still playing. It would do my heart well if more focused on what can be done to get Imetelstat to the patients as soon as possible whether or not commercially available versus continually pounding on Geron and why it needs to go and thinking that is obviously part of the solution while it might just really be part of the problem in the “big scheme of things” if we get a fast BO.

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Mon Sep 10, 2018 7:40 am

I do have a few more thoughts on this so will spin this a little more it. So Geron’s management could use the biobucks and the eventual royalties in a wasteful ineffective manner and that is a shareholder morale killer. Okay maybe that would be possible in a couple years when financial resources really start to pile up but before then they will likely be focused on supporting and possibly growing the scope of the current and additional CTs and transitioning to commercial aspects of getting the product to the patients, etc. Once the royalties become substantially more than Imetelstat plans require, JS and his management team / BOD could have some interest in changing the footprint of the company but only if the stars are aligning properly. But to say, they will destroy the company or are too risky for JNJ to keep around is not driven in my opinion based on any of information in their bio’s or past actions at Geron, so where do all these fears come from or is it just that JNJ/Janssen is so intelligent, so impeccable in their planning and execution that nothing little Geron could do would compare. Really? Seriously?

After all Geron is, at least on paper, the parent company of Imetelstat, not JNJ or Janssen, at least not yet. Generally a parent has a lot more concern about their offspring than any other. Who is fighting for survival here, who is most focused on Imetelstat’s progress and success, certainly not JNJ/Janssen? So far based on what little they have said, Imetelstat is just taking up space in their stable. So who has Imetelstat’s back here, maybe its JNJ/Janssen but we know Geron does. So far we haven’t heard a single word from the JNJ/Janssen executive ranks, nothing just a slide here and there. Maybe that will change by 9/13 with a PR or the BSCC, I hope so but that will be a first. I have a lot of confirmation bias on Imetelstat and even Geron, not so much on JNJ/Janssen, when I see some passion exhibited by their executive team I will change on that count. And how about the JNJ shareholder, are they more passionate about Imetelstat than Geron shareholders? Will they ever be? I don’t think that is or will ever be possible.

Okay so pay and option bonuses has been a morale killer for shareholders. Well, how many millionaires are there in the USA, or California or maybe just the bay area. How many of those are athletes or doctors or lawyers or actors/actresses or stockbrokers or real estate barons, etc. and how many of those have worked harder than JS to accomplish their rewards at the apex of their careers, who are probably on average receiving more than his pay at Geron. Sure those that have worked regular jobs, saved, invested for 30 years can say he and the management team don’t deserve it but do the others deserve it more, not in my opinion. All I’m saying is a little perspective here could help us all cut this CEO and company some slack. Geron’s executive team and BOD appear to be a relatively strong cadre of intelligent thinkers and doers and movers and shakers. They have been a team for some time, and for me anyway, relatively de-risked. Compared to JNJ/Janssen, the Geron team has orders of magnitude more skin in the Imetelstat game and it’s not just about the salary and bonuses, not even close!

cheng_ho
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Re: Geron can continue to provide a key part of the equation

Post by cheng_ho » Mon Sep 10, 2018 8:45 pm

Geron has been out of the picture since Scarlett closed the labs all those years ago.

Sergei Gryzanov was "Geron"... Scarlett is an absentee, over-retirement-age, patent troll.

The sooner JNJ buys GERN patents, the sooner the quest for other TI drugs can start... at least two classes of which are covered by GERN patents!

Gwikley
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Re: Geron can continue to provide a key part of the equation

Post by Gwikley » Mon Sep 10, 2018 11:15 pm

I'll be as brief as possible here. Mr. Scarlett was hired, as was advertised, based on his previous history of grooming a company and then selling it. So, following that pattern, and given the right moment, he will let Geron go. Unfortunately the long term investor is caught between a rock and a hard place, as there is no other "parent" available with a longer term vision as the future of this drug is literally unexplored. JnJ/Jensen will become the adoptive "parents" of a potential "genius".
So while I agree, short term, it is best that Geron is still in the mix, JUST to get the best deal, long term it is a shame for the investor that Geron is on this trajectory. But, as in life, we cannot choose our parents.........it is what it is.

Gwikley
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Re: Geron can continue to provide a key part of the equation

Post by Gwikley » Tue Sep 11, 2018 12:01 am

Sorry for the double post. New at this

biopearl123
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Re: Geron can continue to provide a key part of the equation

Post by biopearl123 » Tue Sep 11, 2018 3:11 am

Gwikley, A couple of thoughts, first of all welcome and thank you for posting. "Mr. Scarlett" is actually Dr. Scarlett and yes he has a history of selling companies and is well suited for his position. As near as I can tell, in my own opinion, he has done a stellar job, jettisoning the stem cell business and making a run for the finish line (ok it was a four year marathon, not the 100) with a lightened load that allowed the company to avoid continued dilution (yes there was some) and too many projects, master of none. There are a couple of soft pieces of evidence that suggest a near term buy out as you suggest may not be the current strategy. One is the recent capital raise which suggests and opt in scenario that will need to be funded. The second happened today with a posting on LinkedIn suggesting office expansion again speaking to a more likely possibility of an opt in over a buy out. In this case it is not impossible that Dr. S saw this from far away hence the unusual and complex opt in/ opt out structure that allows Geron to stay in the game longer rather than get bought out early like his other companies. Also as far as other adoptive parents, it all depends, if Janssen opts in than maybe they will be progressive forward thinking parents, thats not so bad even if you don't get to choose, if not there are plenty of others that might wish to adopt this genius. bp

biopearl123
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Re: Geron can continue to provide a key part of the equation

Post by biopearl123 » Tue Sep 11, 2018 3:31 am

Gwikley, after I wrote my post to you, I saw this on SA (reposted from YMB) so this poster seems to support your idea, here it is:

Some guy on YMB said this:
Robert Blake20 minutes ago
Writing back on this board after long long time for a reason; The Job post is absolutely 100% BO. Place I work, when we acquire small companies, we provide them access to our network through Cisco VPN connection using Secure Phone based RSA tokens/Duo authorizations.. So the case here, JnJ will acquire GERN and provide access to JnJ networks for their employees until Merger process completed.
I say, why not....

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Wed Sep 12, 2018 7:56 am

Okay, thanks for commenting. Those are all fair points and just as my perspective can be disputed, so can most others including the assumptions regarding the senior technical consultant being indicative of absolutely 100% BO, regardless I will leave it there.

I will say that JS has been at the helm for 7 years and at 67 years old has seemed to hold his position with considerable energy, intelligence and effectiveness. IMHO know that I (retired now for 10 years) was and still am healthier, more energetic and capable than many who are decades younger. I am hopeful that most would acknowledge the retirement age issue is bogus when based on age alone. Unfortunately many are quick to disregard the intelligence, knowledge and especially wisdom that comes with age, not to mention having a better grip on what is important In this world and willing to disregard the actuary tables in lieu of achieving something of great value and especially when for the greater good. Being retired is found to be “overrated” for many of us.

Not saying JS is all of that but I suspect he likely ranks highly in those honorable regards just not sure on any aspects of his health. There is no cut and dried retirement age element if one can and wants to continue performing any important role at a high level. I know the reality is that anyone over 60 and frequently over 50 are considered less effective than a younger person because they are simply “old” and “over paid” and not worth investing in. I can personally say that is incorrect but unfortunately doubt much will change there in our lifetimes given all the regulations out there and human nature driving such blanket statements.

As far as grooming and selling the company being JS’s primary purpose at Geron, that might have been the original thinking and maybe still is, I just don’t know if it was that cut and dried. Either way, it is now 7 years later, possibly / likely much has changed regarding intentions and expectations. Obviously the outlook and immense potential of Imetelstat is starting to take shape, wouldn’t running with that torch bring excitement and motivation to one’s desire suit up and get going each day.

I think it is safe to say Dr. Scarlett runs the company, he is clearly in charge and I think we may soon know what he has in mind for both the company and his future involvement. He has been there 7 years and he could likely remain for a few more, or not. Possibly he will pass his position on to another more suited to run a company with the growth and organizational complexities of Geron if it intends to transition to a mid-tier pharma. Just saying it doesn’t have to be a BO now or in 6 months or in a year or even two. It can all be decided when the clarity of Imetelstat’s future is finally achieved in the coming months or years. And that just might be in the best interest of the science, patients and investors. As long as those things come to fruition, hopefully we are all okay regardless of how it flows from here.

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Mon Sep 17, 2018 6:04 pm

So the seriously interesting negotiation process continues or not on how to complete the business relationship with JNJ and future development of Imetelstat. Whatever happened in this space leading up to 9/13 CC has continued to demonstrate JS’s metal, as he is dealing with heavy weights in JNJ/Janssen and FDA/EUA. While certainly in many ways it would be dangerous to walk away from JNJ/Janssen given their size, close ties to / influence with the FDA/EUA, etc. and involvement with Imetelstat as relationships matter and if that would occur, JS/Geron would likely want/need another partner for many reasons. Very low odds this happens as both JNJ/Janssen and Geron want this marriage to work as do most of us. However, whatever happened between the parties prior to the so called BSCC on 9/13 was significant and not likely the planned script.

Maybe its related to the DNA changes that occurred at JNJ/Janssen following the Pharmacyclics deal (debacle) which did occurr after the CA with Geron. Or possibly Geron wants new language added. Given that the de-risked asset has probably been reassessed / revalued, maybe they both want language added around something new like: BOs, alternative suitors, financing, breakup fees, higher percentages, more involvement, trial plans, etc., etc.

What are the sticking points? Well, typical ones have been covered multiple times on ImetelChat, SA and YMB. It is not whether JNJ/Janssen will sign the CA as they want to own and run with the science. They need Imetelstat badly; it is the crown jewel of future successes in cancer treatment. My guess the price is going up daily as it has been a constant stream of positive development and appears that will continue well into the next several months and even years. There are several lists out there but just take a look at the list of positives that biopearl put together on SA, the snowball is rolling downhill now and can’t be stopped.

I believe JNJ/Janssen has been secretive beyond most of our expectations and possibly because they were astounded by the Imetelstat efficacy found in the CTs and pre-CTs far beyond their pre-deal expectations. I do suspect they have been internally plotting how to keep this all from getting away from them and doing a very modest BO. But the sticking points may now be entirely new considerations / options like adding priority to focusing development resources on Imetelstat in combinations and aggressively adding CT’s with an eye towards targets for numbers of NDA’s, not allowing the decision point to balance on if the combination is using Imetelstat versus an internal JNJ/Janssen drug, how to structure and value an eventual BO, etc..

Still it could boil down to JS/Geron not accepting any new or old T’s & C’s or JNJ/Janssen not accepting some requests for changes or even BO from JS/Geron. Maybe it is something in the continuation data package that is or is not there, or is or is not being interpreted fairly. I think it is likely much more and I think likely good news for all with the possible exception of JNJ/Janssen, and I’m not sure even about that for JNJ/Janssen as they should ultimately benefit by taking the high road with their partner, but of course it always seems to boil down to money.

I did find it curious that JNJ/Janssen execs only refer to Imetelstat, never Geron or Geron’s Imetestat and seem to believe they already fully own Imetelstat. Anyway, the catch maybe will be found in the Opt-in/out or some other confidential parts of the redacted CA document that JNJ/Janssen wants renegotiated. I think it is too soon for the BO, certainly could be wrong on that point as the debate rages on and seems JNJ/Janssen already believes they own the prize so maybe cooking that on the front burner. I do seriously doubt the issue was due to a lowball bluff on JNJ/Janssen’s part. Whatever it is, revolves around money, control and the developmental plan of attack from here. What else could it be? And it is not efficacy or safety!

There are many potential aspects that could be going on in the negotiations, it could be very complex or not. May not be the case here, but I have found that those like us “not in the know” will find many ways to imagine infinitely more than reality as to what is going on behind the scenes. While many seem to disagree, and they could be right, I still think JS/Geron has a place in this equation. Getting through the next couple weeks especially will test us all and probably bring out the best and unfortunately the worst. However, in the big picture, all is looking extremely positive to me. Other than watching our investment accounts doing gut-wrenching back flips in all directions with every piece of news or investigative finding by the boards, I am really grateful at what is happening on / around the launch pad. While never soon enough, I believe it will be great news for patients! Like someone (Ed Leviek maybe) said, this is the stuff from which movies are made. Certainly the Geron / Imetelstat saga will leave an indelible mark on many patients, investors, companies and government agencies as it unfolds.

1bordersooner
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Re: Geron can continue to provide a key part of the equation

Post by 1bordersooner » Mon Sep 17, 2018 7:23 pm

very well thought out post. There were several points that I had not considered and I thank you.

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Fri Sep 21, 2018 6:45 pm

Thanks 1bordersooner, if nothing else these posts are therapy for me.

I know some are understandably reading and growing weary of my droning on, while I can’t promise this will be my last on this subject we can hope. Assuming the “deal” has been through several iterations since recent readouts, I wonder if JNJ/Janssen are starting to feel the fatigue most of us have experienced for years since the license agreement, although I doubt it. I believe in this case, their frustration is in large part due to Dr. Scarlett’s experience from his other companies, BO’s etc., and hopefully JNJ/Janssen now realize he is to be reckoned with. Possibly the corporate execs haven’t been paying enough attention thinking this would all play out quietly and now find themselves the deer in the headlights.

Apparently the CA has some bite in favor of Geron, if so it’s likely due to JS’s experience, foresight and recognition that Geron would have staying power while holding the Imetelstat jewels. I personally appreciate his leadership through this period of the “process”. Given the drug is de-risked, the size and maneuverability of the tortoise versus the rabbit will likely be very noticeable from here and in this case it is not a fairy tale. I don’t think the rabbit will let us down or be out maneuvered.

IMHO going forward from the CA and Opt-in, the next steps assuming we have this right, the progress should be mind boggling, again in part due to JS’s leadership, preplanned flexibility and sense of urgency. While not for certain, this will all likely lead up to a BO as the initial blueprint, as mere patients and investors can know it, show the likely future for Geron’s IP, patent farm and options going forward.

Certainly Geron’s options could be a little frightful for JNJ/Janssen and add to their urgency to act as seen by the futile BSCC. From here we should get fair and just price discovery, pushed higher in part by competitive drug companies hoping to share in promises of the science and future rewards. Or if for no other reason than to cause further pain for JNJ/Janssen’s seeming arrogance or plight of the tortoise or whatever it takes to make sure they don’t walk away with a steal.

Just maybe JS has our backs, either way he is the jockey riding the Geron Beauty for us and so far all looks good coming into the final turn of this race! I think an eventual triple crown awaits if not more. Maybe all wishful thinking, but I can’t think of any high odds way to sanely bet against it.

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Tue Sep 25, 2018 12:26 am

Okay so let’s discuss the skeleton crew at Geron as an indication that Dr. Scarlett is thinking strictly BO. There are other signs (some may say tea leaves) as to what he is considering and what he might be seriously considering. We would do well to remember that JS is not flashy or one to make unjustified claims, but he is actually a man of action, a decision maker but those skills used aggressively early on at Geron, have been largely in abeyance for four years but now are heavily into play.

First Dr. Scarlett seems to be perfectly willing to take a risk, especially when he understands the game and has the cards to win the gamble. So as a starter, the extra space in their facility has been suggested by others to be usable for multiple purposes such as marketing staff, research staff and lab and even Imetelstat manufacturing. Of course, Geron is not in any way limited to a single facility and these facility considerations, whether ever acted on or not are options and forms of strength now opening up to Geron. While we can’t know if stripping the company down to bare bones while the CT’s and de-risking process were taking place, it did seem fiscally and managerially prudent , that could change now.

Certainly if there is a time following the Opt-in that Geron needs to establish a more typical biotech corporate footprint, they will have access to the best talent available as a result of the astounding TI science, etc. and IP owned by Geron. Regardless of where the corporate expansions would occur there will be many excellent future employees looking to join the Geron team and likely many of the key leaders and professionals needed are already known and in contact with Geron’s executive ranks.

Depending on the results of Imetelstat in the CTs, likely known to key executives of JNJ/Janssen and Geron now, I would assume that JNJ then might also understand that Dr. Scarlett is in a position to seek rapid expansion of the science in both trials and generating commercial value to Geron. If he has a fair level of control on these decisions and plan of action going forward we might be foolish for wanting to forgo Geron’s role and impact on delivering options to patients and price discovery of the stock price.

Many believe and possibly it proves out, that things are dragging because JNJ/Janssen are following through on all the work needed to provide the full package associated with the CD, and / or working out the final details on FDA/EUA responses to requests for designations or even approvals and / or Opt-in or BO discussions. However, just maybe given the results, JS/Geron are taking strong steps to nail down negotiations for post positive CA such as guaranteeing the highest % royalty, negotiating other redacted CA terms and ranges in Geron’s favor. Possibly JS is aggressively seeking grey area advantages not defined or provided in the CA when originally written and contracted but now of keen interest to both companies. I would expect a strong stance can be taken regarding the trials using Imetelstat in combinations but might need some negotiation to firm up plans. Maybe it’s all cut and dried and JNJ/Janssen will do the right things for patients and Geron investors but I think that is at least partly unlikely and we need JS to stay the course and I think he will but either way I expect we will soon know.

bucbeard
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Re: Geron can continue to provide a key part of the equation

Post by bucbeard » Thu Sep 27, 2018 3:49 pm

ummm...so why is Phil's post from early this morning (telling us not to sell) now removed??? I find that extremely suspicious, concerning and unscrupulous.

Can we talk ourselves through this please?

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Sat Sep 29, 2018 4:52 am

Well for most of us, a day to let our heads clear is not adequate. What just went down does not compute very well for me and is very painful. Obviously I was totally wrong about JNJ/Janssen on practically every level thinking they could not pass this up. I hope for what it’s worth that all know I share a lot of the pain being experienced by patients and investors alike. If I have in any way added to that pain I am deeply sorry. I am in disbelief that the losses and broken dreams that have occurred were justified. and to bucbeard's point, I currently have no way to adequately talk us through this. This will be my last post on this particular topic but since I embellished to the nth degree, and obviously gave many now discredited opinions, I wanted to have one last retort on it and then leave it to "maybe this to will pass".

As investors, people can say all they want about needing / having proper credentials to invest in biotechs, especially ones with a single drug and nothing approved. However, this was not a setup by the positive Geron board contributors on the various sites in recent weeks / months. Most of us have not jumped in at the last moment. We made our initial investments years ago and have increased our positions on many occasions over the years as our understanding of Imetelstat and telomerase inhibition increased. I don’t think we were only looking at one set of facts lined up in what many call confirmation bias, although that may be part of it.

Confirmation bias is obviously prone to be recognized and taken advantage of by the shorts. But even the short contributors increased confirmation bias as a result of their misuse and misinterpretation of facts being provided by the drug principals at various times in the studies and earnings, annual reports, etc.. So, over the years, with each positive step of the CTs (and pre-CTs) and analysis by the boards eliminating much of the glaringly inept negative spin by using facts from history, business and science along with math / statistics in an articulate and substantive manner.

Now I have to say, JNJ/Janssen’s benefits to Geron by coming to the rescue with a small initial cash payment, setting up and running the trials over the last 4 years as the Imetelstat savior doesn’t resonate well with me. This was always an area of concern for me but so many felt they were a great partner and sure path to getting approvals with quality planned and run CTs. I am no expert, but what I saw was mediocre to downright flawed CT specifications, apparently as close to un-approvable as possible, slow set up and initiation and adding patients in CTs, weighted to sicker patients than competitive trials, neglectful of investors and patients hopeful for news showing progress, no effort or expense to provide actual availability of Imetelstat via the orphan drug designation, compassionate use or right to use regulations, arrogance in providing any real respect for a small biotech partner and patients many who may have benefited, no longer alive, etc. Yes, I am cynical and jaded.

After all that, JNJ/Janssen supposedly an honorable corporate citizen provides a brazen, totally un-informational, basically unsupportive statement of Imetelstat, the IP of Geron or Geron in their statement ending the license agreement. I would think that after using up 4+ years of Geron’s life, something a little more closely aligned with reality and reflecting a few obvious positives such as never seen before MOS in the MF trial, transfusion independence or reduction for the greatest percentage of MDS patients of any drug, etc. Just a few factual morsels would have been appreciated and most appropriate. I hope not a single small biotech ever does business with JNJ/Janssen again after watching them chew up and spit out and essentially discredit Geron and just as importantly Imetelstat and telomerase inhibition.

So what about the science, what were the problems with it, really? Can this be pinned down? Are there any facts, I don’t care about opinions, just facts on something great enough to decide not to push forward with this drug? What were the determining factors to bring JNJ/Janssen to end the collaboration? Was it a dozen adverse results or was it 1 or 2 or zero but the good was not quite good enough or totally something else? Maybe they couldn’t get past Dr. Scarlett’s requirements for opt’ing in or BO or other agreement details or all of the above? Maybe they couldn’t politically navigate internally promoting Imetelstat above their own homegrown products or getting favorable feedback from the regulators. Maybe they didn’t think Imetelstat or TI science can contribute enough to their dividends or other financial needs in the short term. Maybe it was all a sham to delay Imetelstat getting to market and dying patients by 5-10 more years and on and on. Will we ever really know? Don’t count on it.

I personally haven’t sold a single share of GERN or option before or after the news broke, my positions have always increased upward. While I’m now in a significant state of financial disarray, I have no plans to sell anything at this point. I expect to see some of the confusion clear up in a positive manner and that is not based on confirmation bias, just looking at the facts we have been given. This isn’t over in my opinion, not by a long ways. Personally, I’m glad JNJ/Janssen is out of it, I just hope they haven’t benefited in any way at the expense of Geron IP, patients or investors. I also hope whatever went down here that has impacted patients and investors lives is fully vetted in appropriate legal venues and carried on their conscious.

biopearl, I hope you don’t feel any responsibility for any of our angst and/or financial pain. You have only been one fairly facilitating important information dissemination and discourse, professional and respectful to all. There is something very important going on here, your leadership and support is important and undoubtedly appreciated by all of us. I just read yours and the other newer posts, so this one will mostly dovetail. I agree that it is time for Dr. Scarlett to step up and start providing leadership that we need and demand. Beginning with providing a much better level of detailed information and sense of where he expects this will go under his leadership.

BurtonLee
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Re: Geron can continue to provide a key part of the equation

Post by BurtonLee » Wed Dec 12, 2018 11:18 am

My current theory is that JNJ has applied for accelerated approval for swertres based on the primary analysis of IMbark and needs the FDA's decision in order to present GERN with a clinical development plan. In other words, swertres result needs to know if a future registration study is still needed for MF or if IMbark is sufficient (and to a more minor extent, whether to include a Phase 4 study to support the accelerated approval). The clinical development plan would need to identify these paths and associated costs for GERN to decide whether to opt in.

I would not be surprised with a joint announcement of accelerated approval and JNJ's opt-in decision. But perhaps overly wishful thinking.

biopearl123
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Re: Geron can continue to provide a key part of the equation

Post by biopearl123 » Thu Dec 13, 2018 8:34 pm

Hunt, I re read your post of Sept 28th and see that I did not respond. Thank you for your kind words. I very much would like to keep this forum alive and continue to hope that Imetelstat will move forward as we hope. The small community here will continue to provide a safe place to share thoughts without worry of personal attacks or bickering. bp

biopearl123
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Re: Geron can continue to provide a key part of the equation

Post by biopearl123 » Thu Dec 13, 2018 8:52 pm

BurtonLee, I would like to respond to your comment but might need a little help with some clarification. I do not understand "swertres" and suspect some spell correct changed what you had intended to say. I will say that your hope for a JNJ opt in decision is likely to be overly optimistic. It looks like Geron and Janssen are done. Dr. Scarlet's "rear view mirror" comment suggested there would be no further dealings regarding Imetelstat and a return of the license to Geron is a pretty final act. I would not be looking to Janssen for any help here although they are committed to provide Imetelstat for a 2 year period. There is still the ill defined remaining agreement for development of an unstated drug based on a different Geron program. If Janssen did apply for accelerated approval it may be that it was denied and contributed to the "walk". But even if it were granted, it would revert to Geron as all the IP and clinical data is in process of doing. I think the idea of op in or op out is now longer relevant. Geron undoubtly is pursuing other potential partners or looking to be acquired. I think that several biotechs are facing expiring patents, shrinking markets, relatively inferior products etc that might find Geron very attractive. One would think Imetelstat would qualify for some form of accelerated approval however based on very good objective data presented at ASH and elsewhere. Whether the FDA agrees is another story. There certainly seems to be significant support from the medical community involved in the studies based on the presentation by Drs. Raza and Macarhanas on Dec 10th. Once articles appear in the New England Journal, and I think they will a la Dr Tefferi's 2015 stunner, wider dissemination of information should follow. Best wishes, bp

huntingonthebluffs
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Re: Geron can continue to provide a key part of the equation

Post by huntingonthebluffs » Fri Dec 21, 2018 9:14 pm

Biopearl, I think you are correct on JNJ/Janssen’s future intentions but it is interesting that they did not rescind the other agreement. I think we are all kept in the dark on any activity that is occurring with regards to the license agreement or those patents. I have to wonder also that now JNJ/Janssen is out of the Imetelstat equation, what positive or negative influence they may be exercising with the FDA on “Imetelstat’s clear path forward”.

And yes, exactly, who knows what the FDA is doing in this space. All we hear about is the endless new policies and actions being taken by the FDA to speed the best drugs through their sieve. I just don’t see it happening and believe Imetelstat is a incredible case in point. I do remain hopeful but very disappointed and sad for all patients and investors on what we have endured.

So the science is strong, what we need now is strong business and CT execution. JS has said we have a clear path with MDS to commercialization. It would be very helpful to know what is / is not included in that clear path, including the medical professions actionable support and what FDA recommendations and support are in hand justifying his enthusiasm regarding that clear path. I also doubt that would be shared with investors or patients but more than to date.

So I do believe an investor and / or medical activist firm(s) with benign and positive focus in their specializations to help put Geron and Imetelstat on the fast path to commercialization is warranted. I personally would only support something with win, win, win, win written all over it versus clear the slate and start over mentality.

karagozoglu12345
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Re: Geron can continue to provide a key part of the equation

Post by karagozoglu12345 » Fri Feb 22, 2019 6:31 pm

Anyone read "Good to Great" by James Collins et.al. ? In an emprical study they have identified characteristics of a great CEO , Level Five Leader they call it. Geron is facing significant challenges and to rise above these requires very competent and aggressive leadership who does not follow a policy of secrecy to avoid perceived troubles ( no one is talking about giving away trade secrets to competition), who does not ignore/overlook interests of the investors, and not afraid to show/express his ambition ( e.g.., "We will do everything we can to accelerate the process toward approval" , "We are following the competition closely and will champion our efforts in the most favorable and timely manner"-advancing such ambitious signals does not in any way equal to over-promise with a potential law suit). Have you counted "speculative" conjectures in GERN message boards? Why would a leader create so much ambiguity and uncertainty? And, the investors' attempts to reduce the uncertainties for the most part fall in deaf ears ( e.g., question about Jannssen's misleading signals was answered in a way to further obscure the question-as such their claim that Janssen made multiple errors and corrected their errors totally ignores the role of the Joint Steering Committee). I think a great leader would not necessarily want to be a CEO and Chairman of the Board to exclude critical oversight in the faithful decisions for a company up against formidable challenges. However, CEO of the type "genius with thousand helpers" ( Colllins, et. al) would not mind such power at all. I think, unfortunately, there is very little we can do to enable change at this time given current circumstances. I hope Geron management proves me wrong with all my heart!

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