News Focus
News Focus
icon url

rfoable1

06/25/06 1:27 PM

#2311 RE: coinstarz #2306

coin,
You probably noticed the tornado of attacks on the Yahoo MB by my coments on the value of the 4-patient results & the suitability Iplex use in T1 & T2 diabetes/SIR. We got into what the approval standards are for insulin adjuncts and all hell broke loose - wierd.

Glad to be out of that here on I Hub, and if some of those folks start coming over here to attack, I'm going to avoid getting into it. I now remember clearly why I stopped paying much attention to the Yahoo bunch. People there go nuts when you state anything they don't like or agree with.

Thank goodness for this reasonable board. Keep it up!

cheers to all longs
icon url

PaulaN

07/01/06 3:55 PM

#2382 RE: coinstarz #2306

"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