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WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:00 am
by rccola335

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:02 am
by MergingCultures
Well done everyone! This has been a long road!

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:08 am
by rccola335
this is great for the EHA meeting next - there will be buzz

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:16 am
by ashah
Kudos to the clinical trial patients.
Kudos to the company and its executives for their perseverance.
Kudos to the BELIEVERS!

May the good forces always overcome the obstacles

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:22 am
by rccola335
so there is a press conference 8am tomorrow morning

I dont see anything as second line therapy to Luspat

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:41 am
by Hoosier Investor
Congrats to everyone.....patients, doctors, employees, and yes even those long-term investors! :D

This is so wonderful to see/read/hear after so many years in which the drug's potential has been relatively obvious to those of us paying attention. I'm so glad the FDA did the right thing and moved the drug forward not just for these LR-MDS patients, but also for the MF, AML, and possibly Lymphoma patients in years to come.

I'm thrilled to read the approval is not limited to patients who have also tried/failed Luspatercept. I had thought that was a potential (likely?) outcome....a potential compromise position by FDA. Instead, the FDA is requiring the patients have a transfusion burden of at least 4 units/8 weeks. This is a much better outcome for patients than requiring them to first try/fail Luspatercept. Those patients under 4 units can use Luspatercept first as it has fewer SAEs than imetelstat. Very good judgement and decision on the part of the FDA.....thank you!!!!

Congrats again to everyone. Hard to believe this day is finally here, but it's well deserved and overdue.

Best Wishes,
Hoosier

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:49 am
by Lekola_
At long last!!

Jingle - cheers!

Bp- thank you for all the great information over the years. What a great board!

Congratulations to all!!!!!

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:54 am
by Bigfun
Congratulations to all! I've been dumb enough to wait over 20 years for Geron to get somewhere like this. Lots of inducement grants and finally they induced the RYTELO baby.

Also of course very thankful that the patients will finally get access to this. I truly wish Fishermangents had a chance to see this happen and take advantage of this new offering in medicine.

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 4:57 am
by rccola335

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 5:02 am
by Ryan
rccola335 wrote: Fri Jun 07, 2024 4:00 am FINALLY

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

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 5:08 am
by biopearl123
RC you are right, I don’t see anything about Lus failure or “second line” use.

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 7:15 am
by kmall
Congrats to all who have weathered this storm!!.....

Losfer words. -Kmall

https://youtu.be/4DrjwpI7PPc?si=yaDus1Zft-wyPf0O

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 8:46 am
by jingledsassy
........Land Ho!!!!!!!!!!!!!!!!!!!!!

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 11:48 am
by bucbeard
deep exhale....and appreciation for the patient community, the Geron team and the knowledgable investors on here that have overcome the odds and the obstacles.

now, let's see where this takes us all from here. onward we go...together...still.

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 2:44 pm
by Ryan
Approximately 80% of patients will be under the Medicare umbrella. The Geron Sales teams has already set up 100s of consultations with physicians et al

The other cool thing about the call was the Congrats being given not only on the Approval but on the labeling.

Land Ho indeed!

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 3:04 pm
by mistergern
Phew!

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 3:35 pm
by FC4364
Hard to believe, after 13 years, I don't know what to do. I keep looking over my shoulder to see if another boulder/landslide is on it's way, LOL.

Congrats to all longs!!!!

And a really BIG THANK YOU to BP whose comments kept the lights on more than once at least for me.

And another really BIG Thank You to Kmall, RC, Ryan, Hunt, HI and many others that populated the board with factual and just good old commonsense comments.

Land HO, indeed.

Re: WE ARE APPROVED

Posted: Fri Jun 07, 2024 5:47 pm
by HOOSIER57
Kudos to those who have held for the possibility of "turtle Island"! :lol:

Re: WE ARE APPROVED

Posted: Sat Jun 08, 2024 9:49 pm
by tutt
Turtle Island reference is a long journey into the past! It's amazing how long some of us have been here. Fascinating science!

Re: WE ARE APPROVED

Posted: Sun Jun 09, 2024 12:09 am
by biopearl123
FC4364, you are most welcome!