By my count, day 60 is Saturday

[biopearl123]

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

[kmall]

Bp - For many more ways then just the above mentioned by yourself, you're a good man. It's a rarity these days. Let's all hope we can ride off into the sunset on this one with you, the darkest of days behind us. God willing.......it's been a long hard ride. -Kmall

[biopearl123]

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???

[biopearl123]

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.

[bucbeard]

Regardless of what happens and how this shakes out, deepest gratitude to the both of you, and certainly others too, for the up-keeping and making this a sanctuary of sanity and information. All the other platforms have been polluted for a very long time.

It is here, that we can "Breathe, breathe in the air Don't be afraid to care Leave, but don't leave me Look around, choose your own ground"

Best to all in the days, weeks, and/or dare I say, years ahead.

[biopearl123]

Thank you bucbeard. Much appreciated.

[earfool]

Biopearl

However, this Imetelstat/Geron adventure plays out, I want to thank you for being a beacon of light and information during the last ... over these many - many years?

I'm glad to see PPS headed up... In typical Geron management style... the entire investment community is waiting for news of the anticipated NDA application approval from the FDA.... so what news does Georn send out.... more Inducement grants for new employees. Has there ever been a company more insensitive to long-term investors in the history of the stock market? Maybe not!

.....earfool

[biopearl123]

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 reassuring that we are seeing full speed ahead, damn the torpedos!.

[LWS]

The Silence Mode

The next working day is Monday (Aug. 21). If we haven't heard by then, then we have "Silence". The EAP is now in place which allows access to and the use of Imetelstat before formal approval. Rejection is highly unlikely, unless there is something we do not know about (possible, but also unlikely (IMO, FUDD)).
======================

REMEMBER the EAP (Extended & Expanded Access Program with compassionate care). That is an interim approval to give all MDS victims (and perhaps others) access to Imetelstat before formal approval. That is now a program in motion as patients' needs are being met.

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

by LWS » Sun Aug 13, 2023 3:02 pm

There seems to be 3 possibilities this week:

1. Acceptance of the NDA by the FDA (most likely and expected) with a timeline for approval
2. Rejection of the NDA (the future is always uncertain)
3. Silence (we are missing something about the 60 days from June 20)

Then there is always the uncertainty of the John Scarlett factor (FUDD).
========================================================
Investor considerations are secondary, but obviously would be helped by the NDA being accepted (60 days from June 20) and approved in a timely manner (post-haste).

[Gwikley]

It has been a long and tumultuous journey to this crossroads. Grateful for this board, and it's contributors, along the way.
Rational, informative, educational and humane. And without advertisements!! lol
Thank you.
gwik

[biopearl123]

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 and 2 but as to silence, there is the day 74 letter rule that could extend the acceptance date should some minor deficiencies in the actual NDA be found and a plan to remediate provided by the filer. I’m going with option 1.

[KTArsenal]

Assuming the FDA accepts the NDA, does this 60 day waiting period for acceptance include "time already served" to potential approval?

Including fast track (if accepted for fast track), couldn't we surmise that an FDA approval by around Xmas isn't out of the question?

Thanks in advance.

And yes. Imetelchat, for me, has been a wonderful, educational tool to learn about the process of CTs, how to understand many CT data, and the inner-workings of a biotech business. I've not once felt that biopearl or kmall have echo-chambered this educational message board to pump Geron or imetelstat. They've been direct and forthcoming, and have added asterisks whenever they felt the need to speak from a subjective standpoint.

Thanks again for having me. Let's hope that we're only hanging on by the edge of our seats--and not a d*mned cliff--as kmall hysterically hypothesized earlier.

[biopearl123]

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 rolling submissions accelerates this , well one can only hope. Best wishes, bp

[LWS]

It seems to me that Geron or the FDA has to say something on Monday (August 21) or we have all been fooled again.
Day 74 is interesting. If nothing is said, I do not know what to think, other than carelessness.
===============

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 and 2 but as to silence, there is the day 74 letter rule that could extend the acceptance date should some minor deficiencies in the actual NDA be found and a plan to remediate provided by the filer. I’m going with option 1

[KTArsenal]

Yeah, I thought so.

I can't find any decent literature on the rules between NDA acceptance, and if the 60 day timeframe in NDA acceptance is included in the approval process as "time served."

You'd think that "unmet needs" might have secured the NDA so much earlier.

I suppose it's because they're on a fat-assed and bloated federal government timeline, and not a "human that's suffering through MDS" timeline.

I didn't strike the expletive this time around, because I feel like there isn't an "unmet need" to do so.

Gah! Opening a beer. Cheers.

Here's to Monday

[biopearl123]

Expletive allowed, especially under the circumstances.

[LWS]

We are at 60 days and it is very quiet. One would think that something has to be said on Monday, for better or worse.

Is this a case of purposeful neglect, or is there some major positive event ‘in the oven’?

The medical information from trials, conferences, KOLs and Webinars appears to be overwhelmingly positive.

[jingledsassy]

Bp you are now in a special class with Kmall....Somebody you don't want to piss off.....[love your probes on ymd to the Putsss]....What a Team you guys are....Rewards are not far off imo....Can't wait for our Toes in the Sand.....Land Ho!!! and Turtle Island for Irish Trader 52....just thinking out loud and sipping chilly crowns....ps I have a feeling this NDA is gonna Morf to full approval...again jmho.....THANK YOU...Enough Said.....opps Toast.....

[biopearl123]

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 and who knows? You have always been a one for a good spirited toast. And I know you have experienced the loss of someone you loved. Many of our readers and contributors have also, and it of makes us all want success for Geron and the patients that might be helped. As to YMB, it’s pretty awful, they really need a moderator, but I do comb it in case someone drops a nugget. Some people there forget that real people have cancer and have feelings and are looking for hope and support. But you did uncover one of my tricks, and that is to prod for information gently and to try to know the answer before you ask the question. As to kmall, he has a worldly wisdom combined with a very sharp mind and excellent research abilities. He has also kept me (and this board at times) afloat when I (and others) were ready to abandon ship. It’s been a team effort that I hope will bare fruit, maybe soon, perhaps in the coming week. Enjoy those crowns. With a little luck you can trade that bottle in for some Pappy. bp

[jayfish101]

I too used to dream of Turtle Island and meeting all my fellow determined Geronites. Now, I think more about the good I could do if I do get a landfall of money. I think of family needs, charities, causes etc. We all could do great things if Geron does great things. We can really pay it forward!