Welcome To The Mannkind HUB On AGORACOM

Edit this title from the Fast Facts Section

Free
Message: CC Adressed My #1 Concern

We certainly don't need any more delays with the resubmission being late September/ October timeframe. Add six months and all of a sudden we are in March for a new PDUFA. And that is only with 90% certainty from the FDA's own records.

My hope is at some point the behemoth which we know as the FDA recognizes this drug is needed. I have never heard Al say it might be possible if the drug is implemented early enough in the disease, it might be possible not only to slow down the progression, but to reverse the progress of the disease. The trials are non-inferiority but if the results demonstrate superiority our long awaited ship has come in.

Swing

Share
New Message
Please login to post a reply