"We have decided to voluntarily withdraw our BLA f
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Posted On: 10/28/2022 7:54:32 PM
"We have decided to voluntarily withdraw our BLA for the HIV-MDR population at this time only after extensive review and deliberation, including audits from three external independent regulatory quality firms. While the Company met its primary endpoints in these pivotal trials, which we think is a clear indication that leronlimab performs well in the clinic, we believe the issues identified in each of the three independent audits related to the quality of the data collection and oversight by the CRO make it difficult to support a successful BLA regulatory submission. "
The value gained by having these three "external independent regulatory quality firms" examine the data was not just to determine if the BLA was worthy of submittal to the FDA, but to also strengthen Cytodyn's case against Amarex. It's no longer he said / she said. It's now "they" said.
The value gained by having these three "external independent regulatory quality firms" examine the data was not just to determine if the BLA was worthy of submittal to the FDA, but to also strengthen Cytodyn's case against Amarex. It's no longer he said / she said. It's now "they" said.
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I hope this bankrupts Amarex. Wishful thinking…
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My comments are just my opinions and should NOT be taken as investment advice.
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