Biotech Values

[DewDiligence]

…40 mg dosed thrice-weekly (as compared to 20 mg daily, currently marketed); this version is progressing in a Phase 3 trial with an estimated primary completion date of November 2012 (study NCT01067521 on www.clinicaltrials.gov).

In this instance, the “primary completion date” (the date when the primary efficacy endpoint can be calculated) is not the time-limiting step for FDA approval; rather, the time-limiting step is the actual end of the study, which is expected to occur in May 2014 (http://clinicaltrials.gov/ct2/show/NCT01067521 ).

40mg of Copaxone dosed thrice weekly will almost certainly be efficacious, but it may not be as safe as ordinary daily Copaxone dosed at 20mg. Hence, the FDA will almost certainly not entertain an NDA for thrice-weekly Copaxone until all of the safety data are in hand, and this means a submission in late 2014 at the earliest.

p.s. This is yet another instance of a clueless sell-side analyst.