RE: 2nd FDA pre-submission meeting5 Jul 2020 21:26
theItalian, if the FDA did require additional information then potentially it could be a bit of a blow to FUM. At best it would cause additional delay...worse would be need for a rights issue to fund the extra work....or they might just delay US approval and concentrate on EU approval (which doesn't appear to have the same 'data' hurdle to traverse).
Of course, even if the meeting is in July, FUM might not get the decision from the FDA (whether they do need extra info) straight away. So an RNS in August could be quite possible.