Replies to post #79670 on NanoViricides Inc. (NNVC)

[Diabolical_Southpaw]

I hope that's what happens. However, who knows if it does break lose or if FDA let's the studies advance based on early tox results.

[ZincFinger]

The mechanism used is an "accelerated approval" (often referred to as an "early approval")

(from the link I posted earlier today):

Accelerated Approval
The Accelerated Approval process, first created by FDA in 1992 and later codified in statute, allows approval of drugs that treat serious or life-threatening diseases and that may fill an unmet medical need, based on a surrogate endpoint that is reasonably likely to predict clinical benefit but is not fully validated to do so.
[[Because with the IVPR applicatons for the MGDs, the therapeutic protein is EXACTLY the missing protein that is the root cause of the condition, acceptance of protein level as endpoint is certain in most cases (there may be a very few exceptions where damage is cumulative and appears to be permanent)]]
In some cases, approval is based on an effect on a clinical endpoint other than survival or irreversible morbidity. A surrogate endpoint is a marker—a laboratory measurement, or physical sign—that is used in clinical trials as an indirect or substitute measurement for a clinically meaningful outcome, such as survival or symptom improvement. For example, viral load is a surrogate endpoint for approval of drugs for the treatment of HIV/AIDS. The use of a surrogate endpoint can considerably shorten the time to approval, allowing more rapid patient access to promising new treatments for serious or life-threatening diseases. Accelerated Approval is given on the condition that sponsors conduct post-marketing clinical trials to verify the anticipated clinical benefit. If these trials fail to demonstrate the anticipated benefits, approval can be revoked.

More than 80 new products have been approved under Accelerated Approval since the program was established, including 29 drugs to treat cancer, 32 to treat HIV, and 20 to treat other conditions such as pulmonary arterial hypertension, >>>>Fabry disease<<<< and transfusion-dependent anemia. Two of the 35 NMEs approved in FY 2012 were approved under Accelerated Approval.