Search found 1665 matches
- Thu Aug 24, 2023 6:40 pm
- Forum: ImetelChat
- Topic: Here’s maybe why we didn’t get priority
- Replies: 19
- Views: 9481
Re: Here’s maybe why we didn’t get priority
Yes, but unless the FDA chooses to approve sooner (not likely), Geron is forced to carry a very heavy financial load that will not be offset by much from EAP
- Wed Aug 23, 2023 10:26 pm
- Forum: ImetelChat
- Topic: Here’s maybe why we didn’t get priority
- Replies: 19
- Views: 9481
Re: Here’s maybe why we didn’t get priority
CKTC, great to see you posting again. It always gives me some measure of reassurance to read and think about your thoughts. A couple of points you brought up worth revisiting. As you point out, COMMANDS 3 and IMerge are not equivalent studies, the former head to head with ESA’s the latter in patient...
- Wed Aug 23, 2023 10:03 pm
- Forum: ImetelChat
- Topic: Not selling a single share
- Replies: 6
- Views: 3919
Re: Not selling a single share
Best wishes Ryan, often feel the need for a vacation from (esp YMB) myself. See you on your return.
- Wed Aug 23, 2023 5:47 pm
- Forum: ImetelChat
- Topic: Here’s maybe why we didn’t get priority
- Replies: 19
- Views: 9481
Re: Here’s maybe why we didn’t get priority
Kmall, interesting. Durability has always been emphasized by Geron as they “differentiate” from the competition.
- Wed Aug 23, 2023 5:45 pm
- Forum: ImetelChat
- Topic: Here’s maybe why we didn’t get priority
- Replies: 19
- Views: 9481
Re: Here’s maybe why we didn’t get priority
I think as the dust settles and we start to get clarity, Luspatercept will probably start as first line therapy, not really a surprise, eventually therapy will fail and patients will move on to Imetelstat. They might even be used in combination, or intermittently after treatment “vacations” no data ...
- Wed Aug 23, 2023 5:11 pm
- Forum: ImetelChat
- Topic: Here’s maybe why we didn’t get priority
- Replies: 19
- Views: 9481
Here’s maybe why we didn’t get priority
rccola makes a strong point. All along Geron has made the point that Imetelstat could be used in the R/S negative population (75%) while Luspatercept was not effective. Anil’s presentations emphasized the same points. But here we see priority review for Luspatercept on trial for all MDS subtypes. Wh...
- Wed Aug 23, 2023 4:00 pm
- Forum: ImetelChat
- Topic: advisory committee meetings
- Replies: 3
- Views: 2722
Re: advisory committee meetings
I suspect it will be months before the ADCOM for Imetelstat is convened. I hope they will ask the leaders in the field to sit on that committee. Dr. Rob Califf is the director of the FDA. He is a distinguished cardiologist. Once he hears Geron’s presentation he may be more disposed to realize that 7...
- Tue Aug 22, 2023 7:25 pm
- Forum: ImetelChat
- Topic: standard review
- Replies: 8
- Views: 6254
Re: standard review
Jay, to clarify: priority review can be granted to NMEs. But a review panel is likely for an NME regardless of standard or priority. Suspect Geron will say FDA is really backed up and having a review board would add time anyway, etc etc.
- Tue Aug 22, 2023 5:30 pm
- Forum: ImetelChat
- Topic: We live and die by the FDA
- Replies: 6
- Views: 2718
Re: We live and die by the FDA
Ryan, an accurate history to be sure. What news remains for this year? Update on the oral agent by the end of the year? 50% enrollment in MF study? Early Rux/Imetelstat data? Probably not a lot near term to enhance shareholder value except a partner/buyout. There are a lot of new hires on the payroll.
- Tue Aug 22, 2023 4:45 pm
- Forum: ImetelChat
- Topic: We live and die by the FDA
- Replies: 6
- Views: 2718
Re: We live and die by the FDA
Kmall, presumably the UK “office” is still on the payroll. It’s a mystery. John has some ‘splaining to do. Be interesting to see Geron’s spin on all of this. They will probably emphasize that well its only 4 months difference and approval could come sooner anyway. You sure have to wonder, the FDA se...
- Tue Aug 22, 2023 3:54 pm
- Forum: ImetelChat
- Topic: We live and die by the FDA
- Replies: 6
- Views: 2718
We live and die by the FDA
Maybe the Europeans will see it differently but in any case we have to live with standard review. Something is a little stinky. Shamefully so. Standard review is still a big deal and we get a drug on the market(eventually) but the uniqueness of Imetelstat has not been recognized by the FDA, it’s jus...
- Tue Aug 22, 2023 4:42 am
- Forum: ImetelChat
- Topic: The thing about timing
- Replies: 5
- Views: 3113
Re: The thing about timing
Saltrock, no question Dr. Scarlett was brought in to get the company in shape to sell, especially after Dr. Okarma made such a mess of things and ran up huge amounts of debt. When that didn’t happen in 2018, after years of work Dr. Scarlett could have had a comfortable retirement (just look at the C...
- Tue Aug 22, 2023 2:40 am
- Forum: ImetelChat
- Topic: The thing about timing
- Replies: 5
- Views: 3113
The thing about timing
The thing about timing is that the market reacts to events. Many are anticipated such as NDA filing, assignment of priority review, approval (how bout that one) and sales (really, how bout that one too). But what would move the stock the most at least short or near term would be a partnership or acq...
- Tue Aug 22, 2023 12:38 am
- Forum: ImetelChat
- Topic: FDA accepts NDA
- Replies: 19
- Views: 9595
Re: FDA accepts NDA
No sh-t
- Mon Aug 21, 2023 5:54 pm
- Forum: ImetelChat
- Topic: FDA accepts NDA
- Replies: 19
- Views: 9595
Re: FDA accepts NDA
Hi Saltrock and thanks for posting. It basically means they get down to business. The FDA reviews in depth for approval. They decide on priority review (a given with unmet needs and great clinical data) so they will assign an approval date and make that public. During this time the FDA may require a...
- Mon Aug 21, 2023 2:33 pm
- Forum: ImetelChat
- Topic: FDA accepts NDA
- Replies: 19
- Views: 9595
Re: FDA accepts NDA
RC, that’s 74 days from filing. Approx 12 days from today.
- Mon Aug 21, 2023 2:04 pm
- Forum: ImetelChat
- Topic: FDA accepts NDA
- Replies: 19
- Views: 9595
FDA accepts NDA
Two more weeks for notification of priority review and PDUFA
https://ir.geron.com/investors/press-re ... fault.aspx
https://ir.geron.com/investors/press-re ... fault.aspx
- Sun Aug 20, 2023 5:57 pm
- Forum: ImetelChat
- Topic: By my count, day 60 is Saturday
- Replies: 23
- Views: 11534
Re: By my count, day 60 is Saturday
LWS, to your point, EAP could not have happened without express FDA imprimatur. It looks to me like a pre-blessing, blessing.
- Sun Aug 20, 2023 5:29 pm
- Forum: ImetelChat
- Topic: By my count, day 60 is Saturday
- Replies: 23
- Views: 11534
Re: By my count, day 60 is Saturday
Jay, love your thoughts about paying it forward. I hope Geron will help you achieve this goal. It is a very high form of mitzvah especially if done anonymously. I think many here will show their gratitude with acts of kindness. Be well. bp
- Sun Aug 20, 2023 5:12 am
- Forum: ImetelChat
- Topic: By my count, day 60 is Saturday
- Replies: 23
- Views: 11534
Re: By my count, day 60 is Saturday
Hi Jingle, it’s funny, when this venture first started, I thought (really) that we would be toasting on Turtle Island for real with Lev, CKTC and Irish. Then I fear I aged (this endeavor has taken forever!)and a long trip, even to a lux far away resort lost some luster, but I do love a nice beach an...