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clock Created with Sketch. 13/02/15
14:36
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Originally posted by pjemmett
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Might as well add my two cents worth although most of it has already been covered. It would appear to me that the FDA may have indicated that the Reach trial did not show enough efficacy to for a NDA without a P3, this was to be expected. With this in mind Prana decides to up the dose as any efficacy seems to be dose related and this looks like a good move to try and ensure that the P3 reaches its efficacy target. This moved has been broadly suggested by many on this board, myself included. The FDA indicate that this will be fine but first you have to show us with ANIMAL (not human) Toxicity tests that the new dose levels are likely to be safe in humans. I cannot imagine what else we could expect the FDA to request, if they really had any doubts about PBT2 they could have requested a complete P2 at the higher dose and that really would have put a big delay and a financial burden on the company. The FDA are covering their rear end which is a large part of their charter to protect the public from potentially harmful drugs. As I see it all of the above was completely predictable and cannot in any shape or form be considered a negative unless you really thought that the FDA would allow an NDA for HD without further trials.
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Well considered and constructed post PJ. [Loved the last couple of sentences - thoughts have gone through my mind]. I wouldn't be surprised to see a much more positive, detailed report by the end of this month, both with respect to HD progress and IMAGINE extension update. [Don't know whether I am prepared to bet on it at this stage though.]
(20min delay)