Quote from Dr. Stephen Hahn FDA Commissioner

[biopearl123]

“I just want to emphasize this point, because I don’t want you to gloss over this number,” he said. “We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.”
Hahn added: “Many of you know I was a cancer doctor before I became FDA commissioner. And a 35 percent improvement in survival is a pretty substantial clinical benefit."

OH REALLY?

This quote was in the context of his comments regarding convalescent plasma treatment for COVID patients. bp

[bucbeard]

Well Dr. Hahn, prove it. Prove your recommitment to this and repair your damaged image by authorizing the same approval for Imetelstat, which has the safety profile and success data to back it up.

[huntingonthebluffs]

biopearl123, that is an interesting analogy, as a 35% mortality reduction is an impressive number in this context as is Imetelstat’s results in MOS for R/R MF as well as, TI in MDS. However, I think it might be comparing apples to oranges if you are looking at MOS in R/R MF vs recovery from a virus. Either way, I believe our consensus is that given everything we know and all Geron & the KOL’s have said, for the FDA to not grant MA seems highly inconsistent. It is especially inconsistent given the level of rhetoric regarding all the regulatory process streamlining done to expedite approval of an urgently needed oncology drug for commercial use. Unfortunately Geron seems to be the "exception to the exception" on application of options to expedite a proven drug to the many patients “gravely” in need. Makes one wonder just what is occurring under the covers and who is selectively influencing the button pushing to supposedly "cut through the red tape".…

[cheng_ho]

PLEASE go read Hahn's apology on Twitter for this "35%" lie. And stop spreading it, it's pure political theater.

We don't even have a controlled study on these "plasma" (really should be "serum" IIRC) experiments... they've thrown pooled blood products (think about that one for a minute, they've been deliberately increasing the risk of blood disease by a thousandfold) into 35,000 people... and yet they had no control group. As one of Hahn's critics said, "we may actually have harmed more patients than were helped".

Anyway, as always, the lie lives on in most people's minds, while the retraction is only on Twitter and page 25 of the WSJ.