Search found 74 matches

by Zhears
Thu Mar 21, 2024 11:06 am
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6830

Re: FDA v. Geron

I am preparing myself for another delay, to knock the approval back from June. After reading the updated risk document a few days ago, which detailed numerous ways the FDA could cause a delay, and the ridiculous showing the FDA did in the first half of the odac, I fully expect some shenanigans. I th...
by Zhears
Fri Mar 15, 2024 2:29 pm
Forum: ImetelChat
Topic: A note from your board moderator
Replies: 3
Views: 971

Re: A note from your board moderator

Has anyone watched other meetings like that and can say the FDA behavior is normal? I thought it was disgraceful. If half of the things they claimed were wrong the study should have been canceled years ago. I'll give it a few days in the hope of an answer, otherwise, I'll try and find some other rec...
by Zhears
Thu Mar 14, 2024 4:54 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5438

Re: March 14th

Watching the meeting. Are the ODAC meetings always like this? The FDA seems to be acting like a prosecuting lawyer. With the evidence the FDA has put forward, if half of it is true, shouldn't they have addressed it years ago or canceled the trial? Is this the time-honored management game of moving t...
by Zhears
Tue Jan 30, 2024 2:45 am
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133410

Re: PPS

I think I messaged you once asking for a negative post. Basically to show the possible negatives had been evaluated in regards to the share price (minus the extreme which would make us all cry). Time has ticked on since I sent that, so I would ask you to expand your view point beyond approval in jun...
by Zhears
Mon Jan 29, 2024 9:43 pm
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133410

Re: PPS

LWS, you may have more success in your goals, if you make repeat posts on other forums, Reddit, or Stocktwits.
Share the information with a wider, less informed audience.
by Zhears
Thu Jan 11, 2024 5:12 pm
Forum: ImetelChat
Topic: 50 New Positions Posted Today.........
Replies: 11
Views: 4216

Re: 50 New Positions Posted Today.........

Kmall, I would suggest that the cost for a sales force is far more than just the wages. All the other costs come along with them. Travel, IT, fat lunch budgets to wine and dine in posh locations, sales pitches which just HAVE to be held at expensive golf courses, all expenses paid. Isn't that the wa...
by Zhears
Thu Jan 11, 2024 11:38 am
Forum: ImetelChat
Topic: 50 New Positions Posted Today.........
Replies: 11
Views: 4216

Re: 50 New Positions Posted Today.........

Once all those salespeople are hired, that's a massive overhead that will eat into gerons cash very quickly. JS has shown repeatedly that he likes to keep the war chest full, so I think we can expect more dilution in the short term to fund them. I had been hoping that a buyout would come before thes...
by Zhears
Fri Nov 17, 2023 10:55 am
Forum: ImetelChat
Topic: Keeping perspective
Replies: 18
Views: 34074

Re: Keeping perspective

I share the same maddening frustration about the share price. I also think that many of us have become too fixated on approval being the end of a long road. Which, unfortunately, it isn't. The share price doesn't care about science, only future profit. Currently, thats all guesswork and still a year...
by Zhears
Tue Nov 14, 2023 9:06 am
Forum: ImetelChat
Topic: Today the EMA Approves Modification to Imetelstat PIP
Replies: 23
Views: 14051

Re: Today the EMA Approves Modification to Imetelstat PIP

The dates are a little confusing here

The decision was made in dec 2022
https://www.ema.europa.eu/en/documents/ ... lan_en.pdf

so what are we seeing here?
by Zhears
Thu Nov 02, 2023 6:53 pm
Forum: ImetelChat
Topic: ADCOM
Replies: 96
Views: 292042

Re: ADCOM

Looking at the past 3 or so years of meeting dates, a Feb date for them to restart seems more probable.
That of course doesn't mean it would be on the agenda then and could be later.

All seems positive and I think we have all learned patience by now.
by Zhears
Fri Oct 27, 2023 9:52 pm
Forum: ImetelChat
Topic: Nov 2nd earning call
Replies: 9
Views: 3412

Re: Nov 2nd earning call

JS has proved time and again the focus is to get the drug over the line. Which really is the only way to make this profitable in the end for shareholders. It has taken years more than any of us would have imagined but that is only really a problem for emotional retail investors. it has hurt quite a ...
by Zhears
Tue Oct 10, 2023 7:50 am
Forum: ImetelChat
Topic: What’s next?
Replies: 9
Views: 9494

Re: What’s next?

Kmall, have you seen any evidence that the company has used a good deal of resources in the UK? When we got the address of the office published, it was the address of an accountant firm on the outskirts of Manchester. The only thing we can read into that is that they have registered a company here, ...
by Zhears
Fri Aug 11, 2023 4:53 pm
Forum: ImetelChat
Topic: NDA submitted
Replies: 22
Views: 13291

Re: NDA submitted

I have had a look just incase its 60 working days rather than 60 days and can't find anything to say it's not 60 days.
But then again, I would assume it was working days for something like this.
by Zhears
Wed Aug 09, 2023 12:30 pm
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133410

Re: PPS

Hi, I was actually thinking of just before JnJ walked and there was the announcement/leak of compassionate use then. I remember saying to friends it must be a shoe in for approval then. It's been a long wait since then. I think there is the risk that we are a little blinkered view of approval and th...
by Zhears
Tue Aug 08, 2023 11:09 pm
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133410

Re: PPS

"Tantamount to approval (EAP) The EAP (Extended Access and compassionate care) is tantamount to approval and bridges the gap before formal approval. Imetelstat is being used now around the world and has been informally approved. We are waiting for the paperwork to get completed before any formal ann...
by Zhears
Mon Jun 19, 2023 11:43 pm
Forum: ImetelChat
Topic: If
Replies: 4
Views: 2411

Re: If

So, let's look at this from the hedge fund manager's point of view. How do you maximize profits over the coming months safely? Dominating the range with volume, automated trading when we aren't in a time of events, keeping SP low until they get wind of a BO? Once the NDA is filed there is a 60 day w...
by Zhears
Fri Jun 02, 2023 11:32 am
Forum: ImetelChat
Topic: Partnership
Replies: 7
Views: 4039

Re: Partnership

A question for those who have followed bio tech and have vastly more experience in sales. If Geron decides to go it alone, when should they start fleshing out an EU sales force? These things take time and a great deal of money. Would a year be enough time to do this? if so they still have time to st...
by Zhears
Thu May 11, 2023 4:13 pm
Forum: ImetelChat
Topic: My exact date prediction for the May Miracle
Replies: 20
Views: 14171

Re: My exact date prediction for the May Miracle

Sneaky Buggers, I sit corrected and shocked. In a nice way.
by Zhears
Thu May 11, 2023 3:09 pm
Forum: ImetelChat
Topic: My exact date prediction for the May Miracle
Replies: 20
Views: 14171

Re: My exact date prediction for the May Miracle

Looks like they went for the ASCO "American Society of Clinical Oncology (ASCO) Annual Meeting. The data in the ASCO abstract will be embargoed per ASCO guidelines until May 25, 2023 at 5 p.m. Eastern Time. ASCO is taking place in Chicago, IL from June 2-6, 2023." rather than the traditional EHA. Gi...
by Zhears
Fri Apr 21, 2023 7:31 am
Forum: ImetelChat
Topic: TAM of 7 billion in the US and Europe
Replies: 3
Views: 2412

Re: TAM of 7 billion in the US and Europe

To get there there is an awful lot of cash needed to fund all the trials and commercialization. I doubt even the doubling of the shares will give them enough cash to do it all. Which leaves the specter of more dilution and reverse splits in the next 18 months. But now the results are out and it's a ...