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Posted On: 10/31/2022 8:44:48 AM
Post# of 148899
well.....unless I mis-heard, we only have 3/5ths of the response to the FDA to lift the hold. and I thought he said the remaining 2 sections would be completed in the "coming months". So we may or may not submit the data to the FDA by YE, and likely the hold won't be lifted in 2022. That's a bummer.
But, I liked hearing that the primary endpoints being hit was still valid. so, no matter how bad Amarex was, the drug efficacy is still unquestioned.
Regardless, my gut is the SP get hit hard this morning, so put on your raincoats.
But, I liked hearing that the primary endpoints being hit was still valid. so, no matter how bad Amarex was, the drug efficacy is still unquestioned.
Regardless, my gut is the SP get hit hard this morning, so put on your raincoats.
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