With respect to the already-expressed views of all those here on hotcopper .... assuming we receive FDA approval on 12th March, would it not be best for Neuren (and all the ROW Rett sufferers too) if the approvals needed by the regulating authorities in other parts of the world are the first order of business. The Neuren in-house expertise would be able to get stuck-in straight away whereas any other company (except for Arcadia perhaps) would have to take time to get up to speed.
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Is it not the case that approx 2 months after the date of FDA approval there will be a large chunk of cash land in our bank account (previous milestone payment was paid 2 months after it became due), so that we will be OK for short-term cash I assume.
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My main point is that it may be best to delay signing ROW agreements because if we are the ones to get the approvals then all risk is "gone" for the new pharmas which sign up, which I would think would result in a higher sign-on fee for us .... and with the extra money we can carry the clinical trials for NNZ2591 further ... and/or have bigger dividends! ...
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Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-37
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