Clearly FDA has concerns about the proposed dosage.
I'm sure they'll give the go-ahead but no doubt with strict monitoring protocols.
I'm surprised the proposed n is only 195 dosed subjects, divided between 150 locations. If I was FDA I would have wanted double that amount.
Regarding funding, $100million for the trial plus quarterly company running costs currently at about $8mill, and probably 3 years until US sales, I'd expect $175mill-$200mill in funding still required. He didn't seem real confident about some aspects of the funding that they are negotiating.
Big concerns for me after listening to the webinar.
research reports and media, page-4296
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