Quote from the latest CC: “ So our PDUFA date is November. That was very nice of FDA to do that, because they found that our application itself doesn’t have any issues or all the issues we had, we resolved them over the past year. They had a question to the DMF supplier, and instead of saying, take this back and call us back in a year or in six months or whatever, they actually said, we need another month to resolve some issues, which is really very promising. And we will update you in November once we hear – if we hear from FDA and what their verdict is.” ………….
It is my understanding that ELITE should hear from the FDA in November (next month) ….. I assume that the original PDUFA date would have been October (this month) but the FDA asked for an extra month, moving the PDUFA date to next month !!!!
I look at it like this: let’s say an approval “moves the needle” 100% …. This extra month gives the share price more time to adjust “move higher” on the most recent 2 launches and then possibly double from say $0.50 rather than $0.35,
IB_🤴🏻
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