Re: Tweet from Prof Kausik Ray
in response to
by
posted on
Jun 02, 2020 09:57AM
I "recommended/like" your post for the scientific, level-headed quality of information that you always bring, but not for the content (that I didn't want to hear haha - not that I disagree) ...
A conditional approval and P4 would be "wishing" for a stodgy bureaucracy like the FDA to go off the grid a bit, considering the miss on endpoints for P2 & P3, for sure. I rest my "hopes" on the quality of the data, which was impressive, especially in newer combo categories, and HF/Hospitalization. Given the overall global health care concerns (Covid potentially overwhelming hospitals, care facilities, and the system overall), and the quality of data from BoM in a few categories, my argument would be slightly refocused to a few of those points given the safety profile, unmett needs, and current health system challenges. It is a tall drink of water (or whiskey) to expect conditional approval and further P4 validation studies, however I feel there is an "argument" to be made. BoM was a wealth of positive information, but again mis-targeted for endpoints in my view, and argumentative nature. Mr FDA let's not let facts get in the way of the truth ... and opportunity ... to save lives, costs, and capacity within the system ... given current system stress, and potential value of apabetalone to patients and payors.
I also think BP commitment and support that is experienced, proven, and respected would be a big help.
Just my "push" from a business and mutual opportunity perspective. I completely "get" your and city's perspectives though, and trust them more than mine. But I would be pushing this off the normal grid as much as possible all things considered, and in consideration of the alleged "new" FDA mentality, and hopefully those conversations are taking place at a high professional, academic, ... and actuarial level.
Wait and see though ... patience ... glta