They had better not start that next trial without a firm commitment as to full approval by the FDA upon successfully meeting pre-specified, FDA-agreed-to endpoints. Otherwise, what do they have to hold the FDA's feet to the fire, and in particular, to consider legal action (which just doesn't seem to be remotely possible on the current facts), etc., when those heartless back-stabbing morons move the goalposts for a THIRD time?!
My big concern now is just MSB keeping the bloody lights on, to say nothing of actually starting that CLBP trial which we have all been waiting for for over a year now. Where is the money going to come from for THAT and this new one (even if run cheaply via academic institutions)?
CR ahead, most likely (back up the truck, shorters!) but will there be much interest? And at what price. Ugh. Talk about dilution...
Roll on 45 days.
Onward, page-8
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