Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

IND for M923 in second half - I seem to recall a 12-24 month approval on these FOB's, correct?

No one knows how long it will take for the FDA review of 251(k) applications because the first such application was just made a few days ago. In any case, it will be at least a couple of years form the start of phase-1 trial for M923 until a 351(k) submission can be made.

p.s. Technically, MNTA is filing a CTA for M923 rather than an IND; CTA is the term used in Europe, where the phase-1 trial of M923 will be conducted.