My exact date prediction for the May Miracle

[biopearl123]

Got your attention fellow board members? It’s May 11th. This is the date the EHA abstracts are made public. We really should FINALLY get our plenary presentation at the June EHA meeting based on a totally new drug and MOA along with unprecedented findings in a PIII study. All primary end points met with lots of zeros after the decimal to emphasize the strength of the data. If that doesn’t do it nothing will. Geron chose to present the TLR findings in a company PR, not a journal, not a scientific meeting. In order to be presented at a major meeting the data must be fresh and not published or presented elsewhere. This is what Geron is saving up IMHO. This is where the inflection point will come. While Geron may know when the NDA will be complete and ready to present to the FDA, they haven’t exactly told us they will tell us when that will occur other than a nebulous before the first half. But they might not tell us exactly they did it! They will certainly request accelerated approval (Lus did not get that). Geron will. I have watched Dr. Scarlett present for almost a decade. This time in addition to brining his usual poised and confident self, he had to “curb his enthusiasm”. I’d love to play poker with this guy… Oh wait, I have been for years! May 11th, the May miracle. bp

[LWS]

The NDA is everything now. I believe that its acceptance and approval is a done deal. Some have talked about the "miracle in May". Will May be the month where everything comes together for Geron, including fast-track approvals and a clear path to manufacturing and commercialization? Has Scarlett chosen his partners, or will there be partners? Where do JNJ and AbbVie fit into Imetelstat's future?

These are interesting times for Geron, associates, patients and investors.

--- from LWS
===============================================================================
bp --- I share your optimism. I understand your logic about the importance of May 11. I also find that JS seemed more 'investor friendly' in the Needham/Geron chat with JS. With that said, John Scarlett has always been unpredictable. Obviously, I hope you are correct about May 11. We will soon know.

[LWS]

Two important abstract dates:

May 11 --- EHA (European Hematology Association) --- Frankfurt, Germany
May 25 --- ASCO (America Society of Clinical Oncology) --- Chicago, USA

[biopearl123]

Conference call May 11, how about that.

[Ryan]

So is it time to start singing "Here Comes the Sun"??

[kmall]

Bp - looks like I just may be losing that $1 bet after all Randolph. -Kmall

https://youtu.be/dv5G7pTt7DY

[biopearl123]

We shall see, Mortimer

[biopearl123]

Kmall, I will PM you my address so you can get the envelope ready. Please also send me yours, just in case.

[KTArsenal]

Whoa, whoa, WHOA!

I want some side action on this wager.

Trading Places is in my top 20 films of all-time, so that's gotta mean something, maybe.

If yes, then I raise the wager from $1 to $1.98 to match the beauty contest hosted by Rip Taylor on television a couple of years before Trading Places was released.

I'm old enough to remember good TV and also Jamie Lee Curtis' incredible bewbs.

[biopearl123]

KT, Careful this could end up costing 1.98 (to someone).

[KTArsenal]

I'm not worried about $1.98.

But as a bonus you'll also receive a bunch of carrots and a crown made of papier-maché

[LWS]

We are all waiting for MAY 11 (EHA Abstracts) and hoping for pleasant surprises. In particular, I would hope for Imetelstat related presentations that discuss: disease modification, survival time, combination progress. It appears that all of the transfusion issues will be dealt with at ASCO (IMerge).

With safety no longer a major issue and patients' needs the major focus, Imetelstat appears to be well on its way to having its NDA being accepted and approved.

===============================================================

IMerge Presentation at ASCO (June 2 with abstract May 25)

Geron Announces Positive Top-Line Results from IMerge Phase 3 Trial of Imetelstat in Lower Risk MDS

01/04/2023

1/ Trial met primary 8-week transfusion independence (TI) endpoint and key secondary 24-week TI endpoint with highly statistically significant and clinically meaningful improvements

2/ Median TI duration approaching one year for imetelstat 8-week TI responders and 1.5 years for imetelstat 24-week TI responders

3/ Statistically significant and clinically meaningful efficacy results achieved across key MDS subtypes, including ring sideroblast (RS+/RS-) status, high and very high transfusion burden and Low and Intermediate-1 IPSS risk categories

4/ Safety results consistent with prior imetelstat clinical experience with no new safety signals

5/ Clinical and molecular evidence support the potential for MDS disease modification

6/ Request for rolling submission of U.S. New Drug Application (NDA) granted and 2023 plans on target for regulatory submissions in the U.S. and EU

[Zhears]

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.
Given that ASCO is roughly 3 times the size of EHA I think we can take that as a positive.

However it may also suggest that the price spike from that news has already been priced in, considering the leak late last month of one of the other abstracts.

[Ryan]

Zhears, perhaps, but EHA abstracts are released at 10AM EST, about a half an hour from this post, so we do not know that yet.

[Ryan]

https://ir.geron.com/investors/press-re ... fault.aspx

[Zhears]

Sneaky Buggers, I sit corrected and shocked. In a nice way.

[FC4364]

Lots of chatter on YMB by Anthony in regards to FDA calendar and the Prescription Drug User Fee Act (PDUFA) date sometime in August.

[biopearl123]

FC, you might want to check the FDA calendar yourself.

[huntingonthebluffs]

FWIW, those dates appear to be emanating from the Geron 10K report in the RISKS RELATED TO COMPETITIVE FACTORS section. Not sure how/why they get to the calendar linked to Geron as the dates reflected are associated with different drugs.

From the calendar links:
GERN GERON CORP PDUFA
When
Friday, Jun 16, 2023
Description
2023-06-16 plc which has a PDUFA date of June 16, 2023 for approval in the U.S.; pelabresib (CPI-0610), a BET inhibitor, by MorphoSys AG; navitoclax, a BCLXL, BCL-2 and BCLW inhibitor, by AbbVie, Inc.; development of parsaclisib, a PI3K delta inhibitor, by Incyte has been discontinued in both the front-line and JAKi treated MF Phase 3 trials. https://www.sec.gov/Archives/edgar/data ... 230331.htm

GERN GERON CORP PDUFA
When
Monday, Aug 28, 2023
Description
2023-08-28 Bristol-Myers Squibb Company, or BMS, has announced that the FDA accepted the supplemental Biologics License Application, or sBLA, for luspatercept for Priority Review in first-line LR-MDS and set a Prescription Drug User Fee Act (PDUFA) review date of August 28, 2023. https://www.sec.gov/Archives/edgar/data ... 230331.htm

[jayfish101]

I have been trying to figure out what the FDA calendar notes mean. No luck, but the June and August dates do clearly say Geron. Maybe it is not for public consumption yet? Maybe they are tentative dates? But, both dates I think are worth noting and the June date sure fits with Geron just saying they will file in June.