Replies to post #113109 on Biotech Values

[Cactus Quave]

If a Minor Deficiency letter indicates that the FDA views T-Enox as approvable in its current form, this raises the stakes of MNTA's patent infringement claim against TEVA. If TEVA's application is based on a drug that infringes on Momenta's patents, TEVA is hardly in the driver's seat.

[kaivamei]

Major vs minor deficiency letter

Does the term "minor" in "minor deficiency letter" refer to the level of deficiency in the contents of an application relative to what FDA needs in order to reach a decision, or is it relative to what might be needed in order for the application to be approved?

Naively, I would guess the former: that it is a measure of how much more data the FDA needed in order to decide on the application (i.e., to determine whether it should be approved or denied.

If this is so, then a minor deficiency letter could just as well indicate closeness to a non-approvable letter as it could closeness to approval.

Would someone with greater knowledge of the workings of the FDA be able to comment on this?