Insmed Inc (INSM)

[PaulaN]

"Another thing about the Byetta approval - insmterry might note that the primary clinical endpoint for the FDA approval was - guess what! - HbA1c reduction at 30 weeks. After all that hoopla about how FDA supposedly changed all its thinking - the "new paradigm" etc. where tracking of HbA1c was dismissed as simplistic..."

I'm sure terry can answer for himself,but I find it truly amazing that your answers are always wrapped around Amylin.Did terry mention this,or as Byetta's current Phase 3 LAR trial(open label)shows(and his point was),convincing the FDA to take a different approach to drug approvals.
Yes, I find it hard to believe that someone"who attended the Symlin meeting",had to explain away(went to the label- a giveaway) no T2 hypoglycemia- an issue very much discussed at the FDA meeting.
The paradigm is changing..in diabetes,and at the FDA- this may bode well for Insmed in the future.
It is no longer about a simple number.
Dr P