Quote:Faster is good but there are no production facilities available that could absorb the approximate $2 Billion that the sale of present inventory would bring in.
There are bioreactors across the globe.
Overseas versions of the FDA are going to be more willing to fast track manufacturing and facility inspections especially in their own countries. Once those come online Samsung can be devoted solely to the U.S. Let us hope Cytodyn has had at least some preliminary talks with some other manufacturers in South East Asia.
Quote:Ken Chowder noted, "At the moment the Philippines
We will also be submitting to the EU, Canada and the U.K.
Quote:If we sold all of our inventory as soon as possible, what would keep the FDA from saying, "Well, since you have no inventory, there is no urgency to your approval. We will set your application on the back burner and set the heat on low. Tell us when you can supply what you ask us to approve!"
What would keep them from doing that is not approving a lifesaving drug in the middle of a pandemic would mean at the minimum Congressional investigations. At worst people fed up with government's response to the pandemic would storm the FDA. Approved overseas it will be a scramble for approval here and facilitating bringing new production online.
If the government was smart they'd lock in a contract for part of the inventory contingent on FDA approval. If Cytodyn was smart they would insist on a non-refundable deposit have only part of the inventory tied to the contract and with an opt out at a specified date if the FDA has not approved. But Azar and Pence are not the brightest bulbs out there and as far as I know nobody in the Administration has substantial blocks of CYDY stock so don't hold your breath.
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