Biotech Values

[Superfly15]

I would assume on the order of a 9 month to 1 year delay. In the big scheme of things that doesn't have much impact on NPV given there is no competitor for the foreseeable future in the entire space and there is unlikely to ever be a generic.

If they started tomorrow they might get it approved within a year, but they are still looking for their lost SPA agreement so who knows how long it will take.

CMC issues were "fine" as of May 2010 http://ir.mappharma.com/releasedetail.cfm?ReleaseID=468542

This is worthy of a class 2 response right off the bat (6 months)

Meeting with FDA is 90 days after application received (3 months) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.102

We're up to 9 months already, and that's IF MAPP submitted their application to the FDA tomorrow and worked everything to a "T."


To say that the FDA did not complete the "usability review" is a bit odd, considering the inhaler is the whole point of the product. MAPP also said that there are no PDUFA delays, which is also BS. If the FDA needed more time, they would have extended the PDUFA 3 months just like they did with PLX, HGSI, etc.

Considering the NDA was submitted on 5/26/2011, there was no reason NOT to submit this "usability study." Correct me if I am wrong but it was done before the NDA was even submitted.

http://www.mappharma.com/file.cfm/124/docs/MAP019_RDD_Web2.pdf

Then again, I don't get paid the big bucks some of these "analysts" do to sit in their office and spout defenses and price targets at 7am in the morning before the conference call has even occurred.

My BS meter is really ticking.