im sorry i have offended you. my issue is with the other posters who make accusations of deliberate deception and disregard for fda recommendations. thats not you but we have to be careful not to fall into using their wording. i dont believe it was clear from the 2nd crl communication that "fda has requested an additional trial to obtain more data" or that this was" the only way forward"
everything isn't straightforward but i believe strong progress has been made between 1st and 2nd crl in areas such as moa linking invitro -invivo and potency.
whether we end up needing it for pediatric approval, an additional trial is happening either way.
i agree with healthy skepticism, it seems so much skepticism now exists in investors with both fda and our management of our applications that it seems to have created a large disconnection between the share price and the chance of approval, magnitude of the near term possibilities, and is being compounded by the funding risk.
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im sorry i have offended you. my issue is with the other posters...
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