Biotech Values

[DewDiligence]

NVGN – In other words, they are unblinding prematurely without any agreement with the FDA to alter the statistical analysis plan:

The Company has decided to assess these data from the Ovature trial at this time, as the current downturn in the global financial markets makes raising further equity or debt in the near term to fund the trial through to completion most unlikely. According to the agreement reached with the FDA in a Special Protocol Assessment, the planned interim analysis of the data can be scheduled only after 95 events of disease progression and full recruitment of 340 patients.

The comments by the ex-CEO in the link you posted appear to confuse the number of patients who completed therapy at the Nov 2008 DSMB analysis — 78 — and the number of progression events at the time of the Nov 2008 analysis, which is surely a number less than 78. If the number of progression events in the Nov 2008 analysis was much less than 78, it’s hard to see how the number of events could now be as high as the 95 events the FDA wants for conducting the final analysis.

Thus, even if the FDA were to overlook the severe reduction in total enrollment relative to the trial size specified in the SPA, it would take a miracle for the PFS numbers to work out satisfactorily.

Why the heck has the share price been rising?