On today’s CC, the rationale for the delay getting the phase-2b trial started was the difficulty of gaining approval for a multinational protocol. This, IMO, is codespeak for a clinical trial that investigators don’t strongly believe in because they don’t believe in the drug to be tested. (GENR used essentially the same language to justify the delay in starting one of the phase-3 Evizon trials until they finally admitted that the situation was hopeless.)
As support for my contention, I offer this:
1. Almost a year has elapsed since the end of phase-2a (#msg-11806828).
2. NVS passed on exercising an exclusive option to license ANA380 (#msg-12538617). Note that this decision occurred before Tyzeka was approved in any jurisdiction of consequence.
3. ANDS and partner LG of Korea are not even talking about running a trial that compares ANA380 to Baraclude or Tyzeka; rather they are talking about comparing ANA380 to Hepsera, which is at best second-rate in efficacy (#msg-16969129).
-- I am hereby proclaiming ANA380 a non-factor in the HBV arena. If I’m wrong, I’ll be the first to admit it.
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