Search found 1665 matches

by biopearl123
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
by biopearl123
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...
by biopearl123
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.
by biopearl123
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.
by biopearl123
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 ...
by biopearl123
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...
by biopearl123
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...
by biopearl123
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.
by biopearl123
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.
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...
by biopearl123
Tue Aug 22, 2023 12:38 am
Forum: ImetelChat
Topic: FDA accepts NDA
Replies: 19
Views: 9595

Re: FDA accepts NDA

No sh-t
by biopearl123
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...
by biopearl123
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.
by biopearl123
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
by biopearl123
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.
by biopearl123
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
by biopearl123
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...