Replies to post #28810 on Biotech Values

[drbio45]

approvable letters

I believe that you submit the data to answer the approvable letter but then the fda has 30(could be less)to decide upon whether they consider it a class one or class 2

[AlpineBV_Miller]

We have spoken with other management teams where the classification was provided to them up front. It appears to be variable, but the question always needs to be asked in these situations.

I've always admired Insamed, by the way, for publishing that letter. I understand the FDA didn't appreciate it (they have the funny idea the confidentiality rules in the PDUFA regs are there for them and not for the drug companies). I think there are few more material things than those letters and all companies should place them in their SEC filings.