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.
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