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Two more weeks for notification of priority review and PDUFA

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

LWS, to your point, EAP could not have happened without express FDA imprimatur. It looks to me like a pre-blessing, blessing.

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

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...

Expletive allowed, especially under the circumstances.

KT, first off thanks for your kind words it been really fun and interesting for me to have so many thoughtful posters such as yourself. I think the time line goes like this. No time served. Clock for review starts with acceptance of NDA, 6 months for priority review and ten for standard. Whether rol...

Thanks Gwik! LWS, as to your comments. Geron has been very straightforward in guiding their intention to file, and when confirming when they actually did file, so it seems that they have committed themselves to us to provide the ultimate status of the NDA at day 60. That takes care of your options 1...

Earfool, thanks for the kind words. I honestly think Geron goes about their business (hiring) while waiting for the FDA to go about theirs. They can’t say much during the FDA vetting process. They can’t buy or sell stock themselves since they are in possession of “inside” info. I find it a little re...

Thank you bucbeard. Much appreciated.

I know the kind of friend you were to Matt. Had one myself once before he drank himself to death. It’s a once in a lifetime thing only a few can understand. But you do. Hands across the water. Best wishes old friend.

You made me laugh yet again.

Hasn’t it though? Thank you kmall, most kind. You have been the best sidekick a buckaroo could ask for. Ryan pointed out that the PR for NDA filing was actually a 6 am event suggesting the actual filing was June 19 so maybe tomorrow???

Best wishes and good luck to all. I look forward to the day when I can sign off, knowing I kept my promise to a dying man I never met and to his son. bp

So much goes on behind the scenes. We can only wonder what John has been up to. Reata projecting 1.5 B sales in 2030. Geron 7B in 2033.

I’m with you, “pretty pretty good”. Hat tip to Larry David.

Yes. Inflammation in cancer is very important and may impact other causes of morbidity and mortality. Understanding the role of implantation better may lead to different combination approaches and also provide predictive value.

Interesting. I wonder what they are afraid I would say?

I wonder if by taking its time to review the NDA now, Geron will be given a shorter PUDUFA date. In theory, since the application was granted rolling review, each module has already been closely examined by the FDA over an extended period of time with the possible exclusion of the last submitted mod...