Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

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huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by huntingonthebluffs » Tue Oct 09, 2018 6:37 pm

I’m surprised there isn’t more discussion on these items. I know I am not qualified to address it. Hopefully others with the knowledge / experience will help out here. I guess I’m surprised if this is the norm in this day and age of technology and communication. If it all is appropriate, read no further just explain in a response. Thank you.

If it is too long, here are some of my questions / thoughts on the transfer back.

What is the data for? Certainly for MF, MDS, and pre-clinicals but what else and what data is not currently in transferrable form today? Do the CT sites maintain some of the data that must now funnel back through Janssen? Is the FDA somehow in the middle of this? Are the data in paper form?

Are there regulations controlling any of this give-back process?

Can they get the MDS data back first if this process needs to take a year? Can the retrieval be prioritized according to CT so we can get on with the MDS P3?

Is Geron ready to take any of the data? If not, why not and when can they be ready? Is Geron’s preparedness a major reason for this taking a year?

Is Janssen still in the middle of some pre-clinicals and are they allowed to finish before returning the results / data? Also, assuming pre-clinicals or other non-clinical trial activities are in progress, could this somehow be reason for delay? Once the agreement was terminated as of 9/28/18, should we assume that new agreements were not needed to allow for continuation of the pre-clinicals or were they simply terminated and Geron will only see incomplete results for anything in progress at the termination? Or might Geron consider subcontracting with Janssen to complete any in-progress pre-clinicals. If terminated, the data should be forth coming in weeks not months or a year.

I don’t know what will be transferred back besides data. Probably lots of paper documents associated with sites, patients, FDA, Geron, etc. Will there be lab materials? Probably but someone with knowledge would need to answer.

While I don’t know what the data management project plans might look like for the transition, some business experience tells me the following (over simplified) represents part of it:

1. The asset swings back on paper fairly quickly. In this case, the license agreement was terminated on 9/28/18 so on paper Geron owns and controls Imetelstat and all patents 100% as of 9/28/18 associated with CLA. This step is likely done following some paperwork. All ancillary contracts regarding sites doing the CTs, subcontractors, etc. will take longer (weeks).
2. Seems to me that the existing data should swing in a couple months assuming Geron’s information systems can accommodate it and Janssen has maintained reasonable separation of files, docs, etc. Assuming Geron has a data processing environment capable of bringing the data in, accessing / protecting /backing it up this is a relatively finite process. Janssen / Geron will need to test and verify this can be done before actually doing it (weeks).
3. The incremental data is a moving target as new data is being created, retrieved and stored somewhere every day. So for the next period of time until Geron’s CRO takes over the CT reins, Janssen will continue to gather / store the CT data providing updated files to Geron on some agreed on schedule, hopefully at least on a monthly schedule. Seems a maximum of 3-4 months for this all to be cut over to Geron / CRO.\
4. I am wondering what Janssen is allowed to keep in their files post CLA, hopefully they must all be destroyed, including backups. Geron would need some verification on this. So clean up and verification will take some time (weeks).
5. What am I missing? There must be a lot more to this and it can’t all be between the lines?

Now what are the reasons for the MDS P3 not starting for 9 months? Is this standard process otherwise the fact that all the sites, patients, etc. being in place might not mean what we thought in terms of going from P2 right into P3. What does FTD really buy us here?

So maybe the P2 isn’t complete yet and won’t be until 2019 allowing the data to mature. This all may make sense but what is the timeline? And what about MF frontline and AML or any of the other possibilities, how many years away are those trials? And of course the combinations are still in the way-back.

I have become impatient like many of us. I think more advocacy by SA and ImetelChat and even some on Twitter and YMB might be in order as collectively we own a huge chunk of the company. Where are Raza and Tefferi, and what are the Geron plans to ramp up this strategy regarding a new lease on life after JNJ/Janssen. I have grown weary of the bashers coming with incomplete, biased and false information continually pushing patients hopes around endlessly regarding this outstanding science. It seems to be time for us to step up our game as just understanding and sharing the science isn’t getting us where we need to be and hasn’t for a long time!

I know ASH and post-ASH are coming as well as quarterly CCs, but might it be time for the key advocates on these boards to get the oar in the water on playing a larger role?

Gwikley
Posts: 31
Joined: Thu Aug 30, 2018 9:05 pm

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by Gwikley » Tue Oct 09, 2018 6:51 pm

You give color to the mindless,endless frustrations around this company. Like you I've no idea of the complexity both technically and legally around the cessation of the CD and transfer of the accumulated data. There is the compassionate consideration as well. Will the current patients be able to receive treatments? Why should they have to suffer. What would seem to be a rather simple procedure, ends up being quite complicated. And, FWIW, (not much for sure) I'm exhausted with the infinite saga.

bucbeard
Posts: 24
Joined: Wed Jul 25, 2018 12:30 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by bucbeard » Tue Oct 09, 2018 8:00 pm

Yes Yes Yes...excellent questions that require answers. Thank you. I echo these and also the notion that we now will find out what kind of leadership we really have. As well, they must understand that core Geron investors are fed up with this drama and demand more transparency and communication soon, else swift accountability awaits them in the near future.

I keep telling myself "Surely, they have taken the appropriate preparations in the event of a break-up with JNJ."

All that said, I still have yet to see any legitimate counter-argument against all the known historical data that indicates that the science is stellar.

Everything is vague: "you will see when the ASH data is released" and "Granted, these failures are in the past and have, arguably, very little to do with current prospects in indications like MDS and MF. However, I cannot help but think MDS and MF will be added to the basket of failed Imetelstat indications."

What is the truth behind the short argument???

karagozoglu12345
Posts: 52
Joined: Wed Oct 03, 2018 12:48 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by karagozoglu12345 » Tue Oct 09, 2018 11:26 pm

Thank you for your post! I have played the same questions in my head as I am sure many other investors as well. It is such an irony that FDA grants fast track yet it takes a year for the transfer process to start Phase III. If there are legitimate reasons we have the right to know. Management should quit being vague on important matters. In the last CC, I would have preferred Scarlett to say nothing about the MOS results because of the embargo vs. obfuscating the issue by stating "median follow up time of 23 months". What happened to " bigger than all of you" and "disease modifying effect" when considering there were one partial remission and no complete remission in MF data? How can anyone hope for survival benefit given the PR/CR data? If one of the primary end point was progression free survival as in some of the other cancer drug trials, we would have nothing to hope for as far as MF results are concerned. Also, so many investors are anxiously waiting for ASH abstracts and ASH conference in December as though these events will make a big difference in the outlook of Imet story. Scarlett already shared (with partial lift of embargo) somewhere between pre-mature and mature data. Scarlett most likely knows the mature data and if it contained strong results he would not have shared a relatively mediocre version in the last CC. There seems to be a culture of unrealistic expectations, wishful thinking and unfounded hope. And, for this reason many including I caught in the hype and lost large sums of money (on paper for me for now). I totally believe we the investors rise up, organize and bring some realism and prudence going forward.

HOOSIER57
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Joined: Sun Jan 10, 2016 6:02 pm

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by HOOSIER57 » Wed Oct 10, 2018 1:46 am

I believe when Geron originally transferred the data to Janssen after the FDA hold, Geron was given 12 months to transfer all data to JNJ. I believe it was done in less than eight months. Perhaps it just to give extra time contractually and will be done sooner... :D

Zhears
Posts: 7
Joined: Mon Oct 08, 2018 12:19 pm

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by Zhears » Wed Oct 10, 2018 9:50 am

Gentlemen,

Its not data that will take time. Its the on going treatment of the current patients, plans, costing, meetings, back covering, more meetings. Waiting for results from other sites, correlating them and then more meetings.

We could read in to any delay all our nightmares, but these things don't respond to our demands. It's healthcare hence it will be slow.
Geron also has to put in place there own manufacturing process, which I assume is no small task.

Ash will be make or break, or just a blip while we continue to wait for the start of trails mid next year, then another long wait.
If the data from Ash is stellar we can begin the merry go round of wishing for a Buyout or JnJ getting into a bidding war if they realize they have made a mistake when another one of there trials fail. However, while I have high hopes for eventual success here, I don't have any expectations of a quick win any more.

karagozoglu12345
Posts: 52
Joined: Wed Oct 03, 2018 12:48 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by karagozoglu12345 » Wed Oct 10, 2018 6:27 pm

I am curious why is there even a chance for stellar data in ASH when in the last CC there was a mention of no CR one PR , vague MOS in MF and just "encouraging" data in MDS to start P3? Scarlett knew the mature data when he presented it in the last CC, and if the data was stellar he could have said there is embargo on the data but they are encouraged by the results from pre-mature data. He opted to share mediocre data. Did he think he could prevent share price from a free-fall tanking? I hope I am missing something and if so it will give me hope to possibly expect something good in ASH.

Ryan
Posts: 38
Joined: Sat Jul 08, 2017 1:41 pm

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by Ryan » Thu Oct 11, 2018 5:13 pm

Hello Kara, It appears you are missing something.

The data was not mediocre.

Have you ever sat in a room where a loved one was told by a doctor that the current therapy is no longer effective, and there are no options left but to minimize pain? In these blood cancers, physicians also find it very difficult to minimize pain in absence of a coma state and extreme exhaustion in absence of a blood transfusion. I'll just leave it at that but recommend anyone reading Kara's comment to go back and read the most recent data, the transcript is available on the Seeking Alpha. Or how about this comment in response to the EHA Oral Presentation (Oral, Presentation).

"Excellent results and safety. Perhaps given safety signals, further trials in combination with BCL-2, MCL-1, BTK? Perhaps even PD-1? Not just MDS but myeloma, other heme malig, Thoughts?"

So I do find your pithy dismissal of the data at odds with experts in the field. If you have further thoughts &/or credentials to share, please elaborate.

karagozoglu12345
Posts: 52
Joined: Wed Oct 03, 2018 12:48 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by karagozoglu12345 » Thu Oct 11, 2018 6:14 pm

Fair enough. Then why so many people are waiting for ASH results and hoping the data improves at ASH? If data is excellent as it is than how can we explain the current share price? Smart money has expert advice and I am sure they are looking at the data. Especially in MF one partial remission and no complete remission would not be much of a hope if I was the patient. Lets hope that it nevertheless prooves MOS benefit over time. I do appreciate even the mediocre results is a ray of hope for very sick patients. And, I do hope this drug is available to them sooner than later!

LWS
Posts: 3
Joined: Thu Jul 14, 2016 2:00 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by LWS » Thu Oct 11, 2018 7:36 pm

Kara---I don't know what you are talking about. The original MF Mayo Clinic pilot trail showed a number of remissions. Imetelstat provides these uniquely. Now we are talking about MOS (Mean Overall Survival), and that data looks very good, in some very sick patients. One definitely can live without a spleen. If MF was treated with Imetelstat and very early symptoms with an advanced delivery system, or in combination, we would likely do much better.

karagozoglu12345
Posts: 52
Joined: Wed Oct 03, 2018 12:48 am

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by karagozoglu12345 » Thu Oct 11, 2018 9:30 pm

Read the last CC on that black Thursday. Scarlett discussed the pre-mature ( mature data being submitted to ASH and under embargo) data regarding both MF and MDS trials. I would love to know if I misunderstood some of the contents of his presentation regarding the trials. Also read biopearls last post.

jingledsassy
Posts: 15
Joined: Wed Jul 13, 2016 4:15 pm

Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?

Post by jingledsassy » Sat Oct 13, 2018 3:29 am

Hmmm is the Kara...... dude Adam f.......the King of shorts....If it looks like a duck and sounds like a duck and walks like a duck....we have a SHORT

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