The typical process for a new drug will take at least 12 or 13 years and many millions of dollars all for the possibility of not receiving a green light from FDA. And... once approved there is no guarantee to prevent law suits. Since the patent is good for 20 years this leaves only seven years or so to make hay while the sun shines, then others enter with knockoffs or generics. So if the target market is not large the product pricing will have to be high. CytoDyn has multiple very large markets in the pipeline. Coronavirus has moved the process along a faster clip and presented another huge market potential.
As a result the BLA process cuts way down on the time to approval and with the consequential cost savings can be enormous. The industry was in effect killing itself with these FDA draconian approval measures. There have been drugs actually more effective than existing ones, yet the company product was not approved. More than a bummer.
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