March 14th

[ashah]

12 yes
2 no

[jayfish101]

Yes!!!!!!!!! Great win for patients, doctors and investors!

[LWS]

12 to 2

We made it over the finish line. There are many other considerations now. The (MOA) will be the subject of many research publications going forward. The FDA accepts almost all ODAC recommendations. Imetelstat's strength, as an important blood cancer medicine, will be in combinations. The safety profile seemed to be the #1 issue.
=====================================

Previous: The benefits clearly are important and significant. The risks are manageable and reversible.

The Positives:

1/Transfusion independence
2/ Overall Survival Time
3/ Disease modification
4/ Two ways to kill cancer cells (MOA) -- normal cells OK
5/ Off label uses (in combination --- chemotherapy and other promising combinations when approved)
6/ Very good safety profile
7/ KOLs, publications, conferences
8/ Quality of life

The Negatives:

1/ None available that appear medically important

[Ryan]

Very entertaining... worst fear than any horror movie I have seen. Would have been perfect... except this is real life, impacting real patients and real families.
I am ashamed at the incompetent FDA members and the panelist who voted no. May their family and friends never get this disease.

Ash a bit harsh in re FDA but I see where you are coming from. One Doc on the ODAC voting committee made a point to bring up that she had been on numerous ODAC meetings and never had the FDA and Applicant been at such odds, polar opposites I think she stated. She found it confusing and hard to interpret.

[huntingonthebluffs]

Vote was 12-2 as follows:

1. AC-Joan Powell YES
2. AC-Ravi Madan(Chair) NO
3. AC-Neil Vasan YES
4. AC-Jorge Nieva YES
5. AC-Daniel Spratt YES
6. AC_Christopher Lieu YES
7. AC-Ashley Rosko YES
8. AC-Mark Conaway NO
9. AC-Anthony Hunter YES
10. AC-David Mitchell YES
11. AC-Toni Choueiri YES
12. AC-Pamela Kunz YES
13. AC-Ranjana Advani YES
14. AC-Jacqueline Garcia YES

[KTArsenal]

I think shots are in order.

12-2 should definitely be shots in order.

What's your flavor?

[huntingonthebluffs]

Yes, I agree. Unfortunately I don't drink anything stronger than coffee. But if I did, it would be Wild Turkey Liquor.

[KTArsenal]

Cheers to a nice medium-brew coffee and a bagel with cream cheese or butter and lox. Whatever!

Shots of espresso all around!