WE ARE APPROVED

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rccola335
Posts: 613
Joined: Sat Sep 28, 2019 10:00 pm

WE ARE APPROVED

Post by rccola335 »

MergingCultures
Posts: 11
Joined: Mon Aug 27, 2018 8:12 am

Re: WE ARE APPROVED

Post by MergingCultures »

Well done everyone! This has been a long road!
rccola335
Posts: 613
Joined: Sat Sep 28, 2019 10:00 pm

Re: WE ARE APPROVED

Post by rccola335 »

this is great for the EHA meeting next - there will be buzz
ashah
Posts: 62
Joined: Wed Jan 09, 2019 1:32 pm

Re: WE ARE APPROVED

Post 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
rccola335
Posts: 613
Joined: Sat Sep 28, 2019 10:00 pm

Re: WE ARE APPROVED

Post by rccola335 »

so there is a press conference 8am tomorrow morning

I dont see anything as second line therapy to Luspat
Hoosier Investor
Posts: 253
Joined: Thu Jun 18, 2020 5:48 pm

Re: WE ARE APPROVED

Post 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
Lekola_
Posts: 19
Joined: Thu Jun 04, 2020 4:31 pm

Re: WE ARE APPROVED

Post 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!!!!!
Bigfun
Posts: 11
Joined: Fri Dec 23, 2022 3:23 am

Re: WE ARE APPROVED

Post 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.
rccola335
Posts: 613
Joined: Sat Sep 28, 2019 10:00 pm

Re: WE ARE APPROVED

Post by rccola335 »

Ryan
Posts: 673
Joined: Sat Jul 08, 2017 1:41 pm

Re: WE ARE APPROVED

Post by Ryan »

rccola335 wrote: Fri Jun 07, 2024 4:00 am FINALLY

https://ir.geron.com/investors/press-re ... fault.aspx
Indeed.
biopearl123
Posts: 2591
Joined: Fri Jul 20, 2018 5:13 pm

Re: WE ARE APPROVED

Post by biopearl123 »

RC you are right, I don’t see anything about Lus failure or “second line” use.
kmall
Posts: 1024
Joined: Thu Mar 21, 2019 3:57 pm

Re: WE ARE APPROVED

Post by kmall »

Congrats to all who have weathered this storm!!.....

Losfer words. -Kmall

https://youtu.be/4DrjwpI7PPc?si=yaDus1Zft-wyPf0O
jingledsassy
Posts: 66
Joined: Wed Jul 13, 2016 4:15 pm

Re: WE ARE APPROVED

Post by jingledsassy »

........Land Ho!!!!!!!!!!!!!!!!!!!!!
bucbeard
Posts: 111
Joined: Wed Jul 25, 2018 12:30 am

Re: WE ARE APPROVED

Post 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.
Ryan
Posts: 673
Joined: Sat Jul 08, 2017 1:41 pm

Re: WE ARE APPROVED

Post 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!
mistergern
Posts: 221
Joined: Sat Mar 19, 2016 3:48 pm

Re: WE ARE APPROVED

Post by mistergern »

Phew!
FC4364
Posts: 35
Joined: Sun Dec 23, 2018 11:02 pm

Re: WE ARE APPROVED

Post 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.
HOOSIER57
Posts: 10
Joined: Sun Jan 10, 2016 6:02 pm

Re: WE ARE APPROVED

Post by HOOSIER57 »

Kudos to those who have held for the possibility of "turtle Island"! :lol:
tutt
Posts: 6
Joined: Tue Apr 12, 2016 1:55 am

Re: WE ARE APPROVED

Post 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!
biopearl123
Posts: 2591
Joined: Fri Jul 20, 2018 5:13 pm

Re: WE ARE APPROVED

Post by biopearl123 »

FC4364, you are most welcome!
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