FDA accepts NDA

[biopearl123]

Two more weeks for notification of priority review and PDUFA

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

[rccola335]

So now we have 74 days to be given PDUFA date

[biopearl123]

RC, that’s 74 days from filing. Approx 12 days from today.

[rccola335]

Thanks I was just reading that. Because Friday was 60 days been a long road and hopefully we can get this approved in the next few months.

[FC4364]

Houston, Crawler Transporter has delivered rocket to launch pad.
Mobile Launch Table is connected to launch pad.
Final Countdown begins
Main fuel tanks are filled
Launcher subsystem being checked
Flight Programme is loaded into computer

Countdown at

- 6 min 30 s countdown is automatic


A shout out to Bp, thank you. Intelligent voice when one was direly needed, which was quite often. LOL

Kmall, a shout out for that most needed research and another calm voice, sometimes a What the Frack (WTF) in there but cool. Also a fellow mariner, ran out of Haulover and Government Cut many times, thank you.

Thanks to all and this board is the exception, not the norm.

FC

[Saltrock]

Thank you biopearl, kmall, and everyone else on this board who over the years has contributed so much.
I have watched, read, and learned so much from you all!!
Having been onboard since the old days of stem cells it’s been a challenging and long ride navigating disappointment over and over again.
I’m excited to finally be standing in the doorway with you all. Fingers crossed…..Let’s getter done!!

[Saltrock]

Two more weeks for notification of priority review and PDUFA
In layman’s terms what exactly does this mean?

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

[biopearl123]

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 an expert panel to review and make recommendations. It should all happen within six months of today if not sooner. We could have a drug on the market early 2024. bp

[LWS]

Everything seems to be falling inline in the medical world for Imetelstat. The investment world (Geron's PPS) so far is another story.

The line: Conferences (ASCO, EHA), KOLs, Webinars, MD Anderson, NDA submitted, EAP, NDA accepted, timeline in 12 days with more updates). I see no more obstacles on the medical side.
========================

Re: NDA submitted
Post by LWS » Mon Aug 14, 2023 11:38 pm

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.

The formal approval will come in a fast-track, timely manner after the NDA acceptance. There is nothing on my radar that would interfere with acceptance this week. I believe all medical paths have been followed, with great success. Imetelstat's trials and endorsements from all over the world (KOLs, Webinars, MD Anderson, etc.) insure Imetelstat's formal acceptance and approval.

[LWS]

Consider off-label possibilities when NDA is approved

There is almost unlimited potential for Imetelstat as a blood cancer treatment and beyond in combinations and other types of telomerase cancers (solid tumors for example). When approved new and ongoing trials can be supplemented with off-label uses in many situations.

[Ryan]

Patience of Job. Period.

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 an expert panel to review and make recommendations. It should all happen within six months of today if not sooner. We could have a drug on the market early 2024. bp

[biopearl123]

No sh-t

[Ryan]

HA

[mistergern]

Fingers crossed that we’ve weathered the storm and land is in sight. Best wishes to all and to all a good night.

[LWS]

The FDA has put an EAP in place (informal approval) so all (i's) can be dotted, and all (t's) crossed. The timeline is flexible for final approval of the NDA.

[cheng_ho]

(?) The FDA rejected priority review for Imetelstat... EVEN THOUGH WE HAD FAST TRACK!

This is how they kill biotechs... just delay delay delay.

18,000 FDA employees, and they can't do priority review for Fast Track drug? Absurd.

[kmall]

FC4364 - Appreciate the shout out. Have done Govt cut twice myself, and quickly learned on a Catamaran sailboat with undersized engines the importance of timing not only the tides, but the sea state when venturing in or out of inlets. We've done our best to avoid Port Everglades since traversing that inlet under unfavorable conditions when we first jumped aboard fulltime 4yrs ago. Fort Pierce which until recently was our home away from home is another one that we've sat outside in the ocean for hours waiting for the tide to turn in our favor. But our most memorable inlet was actually having to ditch into Ocracoke, NC one mid November afternoon as a storm system barreled in several hours earlier than expected having just rounded Hatteras, leaving us another 8hrs or so to the tip of Point Lookout. The Coast Guard basically hung up the phone on us. TowBoat US advised on not recommending doing so and said "they could always use another customer"......but they did tell us to stay close to the red bouy coming in.....which when we got closer quickly realized it was where the green bouy should be, and the green one was high up on the beach. A total s#&t show. We later found out that the sea buoy had been "sheared" in half by another vessel and was now underwater. Ended up getting extremely lucky with the tide going in and 8' foot waves with a tidal surge pushing us through as we surfed it in between the breakers while watching the depth finder quickly go from 16' to less than 2' under the keel in about 30 seconds..... managed to round the point turning towards NW, before feeling the bottom skip over sand and then within another 50 yards or so come to a complete stop. Ended up grounded on the beach on the backside of Teaches Hole.....which was at least 100 yards where it should have been according to the chart. Teaches Hole was named after Edward Teach.....or more commonly known as Blackbeard. It just so happens to be where he was captured by the British Navy and killed almost 248yrs to the day that we grounded there.....lucky for us, it was soft sand and in a Catamaran, we simply had to wait for the tide to come in before venturing on into Spring Lake. As foolhardy as a decision that it was to attempt Ocracoke as a ditch out spot in the first place, we earned our stripes that day from fellow seasoned "cruisers" who were left scratching their heads as to how we were sitting in Spring Lake since our mast is to tall to go into from the ICW. We waited it out there several days and simply headed back out by following the line on our nav chart during the outgoing high tide on the next possible beautiful morning, triumphantly resuming our journey south. I swear to you that Blackbeards ghost climbs aboard everytime we pass that inlet now. Glad I've been able to provide a little support for the members and readers of this board over the years and I truly appreciate being mentioned in the company of Bp......that is an honor in itself......I can assure you that in comparison to being a Geron shareholder these past 10+yrs, navigating my way into Ockracoke inlet that day was a total breeze!..........What The Frack!!! -Kmall

[rccola335]

The FDA has put an EAP in place (informal approval) so all (i's) can be dotted, and all (t's) crossed. The timeline is flexible for final approval of the NDA.

there is a bozo festival of clowns at the FDA - to have a drug with fast track/ priority review for treating a hematologic malignancy with unmet needs and to take one year from the time of submission of the NDA is unacceptable - it is like the DMV on steroids

I hope you are right that it could be faster but I would be surprised if it was

[LWS]

Reasonable & Flexible Timeline:

It seems to me that we are dealing with Imetelstat's science, medical successes, a very unique medicine and patients' immediate needs vs. FDA's bureaucracy. I see no meaningful problems with Imetelstat, but the FDA will go by its own procedures, like them or not. I believe (hope) that-- on reflection-- a flexible, reasonable date can be found that pleases all parties. That is to be determined.
=============================

LWS wrote:

The FDA has put an EAP in place (informal approval) so all (i's) can be dotted, and all (t's) crossed. The timeline is flexible for final approval of the NDA.
-------------------------------------------------------

post by rccola335---- at the FDA - to have a drug with fast track/ priority review for treating a hematologic malignancy with unmet needs and to take one year from the time of submission of the NDA is unacceptable---

I hope you are right that it could be faster but I would be surprised if it was

[LWS]

Time Issue now front and center:

It still comes down to patients' unmet medical needs (today), and the FDA fulfilling its mandate. As has been pointed out (by Kmall) the FDA (also EMA and MHRA) is not locked into any timeline and can move very quickly when needed (COVID example).

The time issue needs to be pressed, considering the very special circumstances surrounding Imetelstat.

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

Time & Timelines:

The line of evidence: Conferences (ASCO, EHA), KOLs, Webinars, MD Anderson, NDA submitted, EAP, NDA accepted, timeline (continuing question). I see no more obstacles on the medical side.