Re: A Leading Indicator Of Success: Failure And Risk In Biotechnology
posted on
Jul 08, 2013 11:25PM
Edit this title from the Fast Facts Section
Baba,this surprised me when I found it...
Al:
As you heard from Hakan, since our May 4 meeting, we've had a number of written and personal interactions with the FDA. One interesting input from the agency was an indication that it would accept a resubmission for the initial approval just for Type 1 alone, followed by data in Type 2 as an efficacy supplement. I do not know of any precedent for an indication for insulin in only Type 1, while we see this suggestion from the FDA as still another positive indication, and as an alternate opportunity, should it become relevant. In any case, our intention is still to submit for both indications simultaneously. Though we will be able to reassess this should it later seem advantageous to gain an early approval for the Type 1 indication.
http://seekingalpha.com/article/285268-mannkind-s-ceo-discusses-q2-2011-results-earnings-call-transcript?find=type%20II&all=false