I agree today's call was great.. But I think Nader has a rabbit up his sleeve....
FDA should not be requesting data from a Mono-therapy trial to gain approval for combo-therapy. I think if he can get the data together with this new company, BLA might just be filed for Mono and Combo at the same time, and that is why this BLA is taking so long. This would cause global shock and awe in the entire bio-pharma world, and HIV communities.... Everyone would know our name.
FDA should not be requesting data from a Mono-therapy trial to gain approval for combo-therapy. I think if he can get the data together with this new company, BLA might just be filed for Mono and Combo at the same time, and that is why this BLA is taking so long. This would cause global shock and awe in the entire bio-pharma world, and HIV communities.... Everyone would know our name.
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