(Total Views: 305)
Posted On: 10/15/2025 6:14:31 PM
Post# of 158087
It strikes me, that We have been considered "A Salvage Therapy" for some time... all the while trying to coax the body to reconfirm its authority over self.
Dr Jay above all,...understands that.
The goals that need to be achieved are Safety...Efficacy. After 1600 plus patients,...safety in general is not considered an issue.
The playing field from the view of the FDA lens,... was in recent memory fraught with gotcha moments. All from the rear view mirror.
It seems their regard for us has also morphed over time while Dr. Jay has been in the saddle.
The dynamics and MOA have seemingly changed over time,...while navigating the best possible uses of the drug...
In any game,... there are rules that must be adhered to by both sides...to reach a satifactory end in sight.
I am confident in our front line players.
Dr Jay above all,...understands that.
The goals that need to be achieved are Safety...Efficacy. After 1600 plus patients,...safety in general is not considered an issue.
The playing field from the view of the FDA lens,... was in recent memory fraught with gotcha moments. All from the rear view mirror.
It seems their regard for us has also morphed over time while Dr. Jay has been in the saddle.
The dynamics and MOA have seemingly changed over time,...while navigating the best possible uses of the drug...
In any game,... there are rules that must be adhered to by both sides...to reach a satifactory end in sight.
I am confident in our front line players.
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