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Wednesday, December 30, 2015 8:27:17 PM
First of all, the randomization and enrollment numbers line up perfectly for a look at efficacy in my opinion. If the data shows at least 6 months PFS likely, then they might get marketing approval with a confirmatory that requires no more patients to be randomized. If efficacy shows at least 4 months pfs likely, then they might get marketing approval with a confirmatory that requires no more patients to be screened.
If they are currently looking at efficacy, then LP's proven character would require preparation for all possible outcomes. She is a control freak. That is absolutely undeniable. As a control freak, anything she cannot control must be dealt with in some other way. The most likely result of an efficacy look is continue, but she appears to have prepared for the less likely marketing approval, and the still less likely halt for futility.
She has apparently prepared for the possibility of an early marketing approval by dumping huge $ into getting production capacity up to the levels that would be required, probably with all the automation they can come up with in the time alloted. And she has apparently prepared for the tiny chance of futility by putting some (key?) patents out of the reach of creditors.
If the above is true it doesn't mean anything nefarious is going on, nor does it mean a default is likely. But it does explain the bazaar things going on lately, in my opinion.
The only disturbing issue would be the apparent plan to default if DCVax-L gets called for futility. One might think they could survive that and limp along till Direct matures. But that is not the apparent plan in my opinion.
It would be in LP's demonstrated character to prepare for a finding of futility even if she thought the odds of such were very tiny.
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