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Posted On: 07/30/2020 5:14:24 PM
Post# of 148949
Re: bwolfy2002 #46150
No date for the meeting, just that the request to meet should be submitted Monday and as FDA will have all of the HIV mono-therapy data with the BLA update the request will ask for both the HIV-combo and HIV-mono to be included in the application review. If approved this would be a significant increase in the LLM HIV market, a much welcomed positive outcome.
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