Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

* Synthon hasn’t had any real discussions w/ FDA around
application, development strategy, which is now even more
challenging given structured communications mandated by
Gdufa

Polly,

The 'structured communication' program has turned out to be a nightmare. What it boils down too is that the FDA will only communicate with the companies (momenta) by a final decree. There is no more give and take conversations that occurred years ago. This procedure is the main reason we are seeing so many CRL's being issued by the FDA.

Starting on October 1, 2012 or upon enactment of the program, whichever is later, FDA will issue complete response letters, rather than discipline specific letters, for all ANDAs,
including those pending on October 1, 2012.

? Complete response letters will reflect full division-level review of deficiencies from all relevant review disciplines, including inspections, and address other matters relating to the ANDA and associated DMFs as well as consults with other agency components (these will be subsumed into the application metrics).

? FDA reviewers will make every reasonable effort to communicate promptly to applicants easily correctable deficiencies found in the ANDA and will utilize an approach similar to the NDA review process whereby FDA uses telephone information requests to address easily correctable deficiencies during the review process before and after issuance of complete
response letters.