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Re: reg2015 post# 141143

Tuesday, 10/31/2017 6:47:41 PM

Tuesday, October 31, 2017 6:47:41 PM

Post# of 700458
It is difficult to market an oncology drug without a median PFS gain to report. In the context of a potential competitor who would have both PFS and OS numbers, this is even harder. Only handset can tell us that IMUC would ultimately fail.

The fact that patients are living longer, and IMHO those randomized to treatment had taken much longer to even event than estimated, means the study went on, and on, and on. As Lind L, stated that's not necessarily a good thing. Funds dried up and manufacturing capacity sat relatively idle, except for Expanded Access Program use.

BTW - expanded access programs are regulatory approved and intended to be used to speed access to promising drugs.... would that be considered good news if say 100+ patients were allowed access outside the p3 study while we waited for people to event?
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