Thank you for your response @Showtime. I accept your concerns...

Thank you for your response @Showtime. I accept your concerns given what happened.
I listened to the whole day when the ODAC debated REM-L . It was one hell of an eye opener. Huge respect to SI and the way he and the team handled the day. Listening to the way the “experts” discussed, questioned and listened, I found the process reassuring. Even the dissenting voice in the 9-1, I could initially understand, but felt by the end that his mind was made up from the FDA briefing paper and I suspect personal interest/bias. So overall I am satisfied with the ODAC, but accept this is the only deliberation I have ever listened to.
Where I agree with you, the key question moving forward is whether we can have faith in the new people at the FDA.
Many an accusation as to why they went against their panel recommendation has been aired on HC.
My view initially was that individual hubris and failure to truly understand what Rem-L offered was to blame. I still think that had a part to play, but more leaning towards a process rather than an outcome was to blame. It is (hopefully shortly to be was) why pharma have been able to (IMO) game the system. When I read some great posts on how they were able to get RUX’ approved, it strengthened that view.
Now moving forward, they are insisting of a ODAC for that Alzheimer’s drug. New broom, new emphasis? We will see.
Look they need tools for their toolbox. Some drug companies in their promotion of opioids and I suspect devising of trials, selection of patients and primary endpoints, have acted like “tools”. SI and his team appear to be made of better stuff. We have a solution to SRGVHD, CLBP and opioid addiction, Covid Ards and its long term effects, Heart disease, etc. Our tools are safe to use and effective. Every new US administration likes to have “winners” and every head of any agency wants to leave a legacy. Here we have a great opportunity for the new broom at the FDA, to show they are tough but are resourceful enough to enable the safe introduction of the therapies that their citizens desperately need.
While there will be obstacles, we will negotiate them as we now know how!
Regards
Yelrom