Australian newspaper article, page-200

Hi (again)

re " The guideline (in the section above my highlights) also states that the FDA will respond with an additional CRL within 14 days if the resubmission is incomplete."

Not a 'CRL'. You only get a CRL if, and only if, you first lodge an apparently complete resubmission. In this particular situation MSB might, at most (if its a fiendishly complex stapling issue) get a letter.

It's the FDA's acceptance that the resubmission is sufficiently complete that entitles a sponsor to get a review i.e. a complete review. Oh, and one has to pay them a squillion dollars as an application fee, which FDA will definitely bank at the same time (NB: I think MSB'll get off with a half-fee on this particular resubmission application).

Until then...(see my post immediately above)

Cheers