Avid Bioservices Inc (CDMO)

[biopharm]

Vinmantoo, when you stated:

You seem to be confused as to the role of the FDA.

I do truly think you should look at how the FDA is changing and changing radically on drug approvals, especially on what just happened with Sunrise Phase III. You do realize that the Bavituximab + Docetaxel beat out all historic read outs for the MOS of Docetaxel... right?

If you read up on this, you should realize that things can change quickly. Remember ... the Bavituximab+Docetaxel arm performed as expected and the other reasons for the control arm to "drastically..outperform" 20 year norms is astronomically statistically significant and Garnick will win that debate with the FDA.

How The FDA Could Change The Way It Approves Drugs

New research from a pair of MIT economists argues that the Food and Drug Administration, which decides which new drugs get to market through randomized clinical trials, is too one-size-fits-all in its approach to the approval process for treatments for everything from leukemia to the flu. As a result, they say, the agency is too conservative in regulating trials for severe diseases like pancreatic cancer and not conservative enough when it comes to drugs for less dire ones like prostate cancer.

“The FDA is staffed by extraordinary individuals, but we’re focused on providing them with another tool to focus on desperate patients who have no other recourse,” said Andrew Lo, a professor of finance at MIT and the author of the new working paper. Lo, along with his student Vahid Montazerhodjat, argues that the agency’s judging of clinical trial requirements by a uniform statistical standard is a mistake. Instead, they say, the standards should take into account the severity of the diseases that the drugs seek to address. The Washington Post had a nice write-up of the paper’s implications, and Lo’s statistical approach to the problem is worth exploring further.
..
..
http://fivethirtyeight.com/features/how-the-fda-could-change-the-way-it-approves-drugs/

The paradigm shift into Immunotherapy will cause the FDA to adjust with the times, especially when loopholes exist to make a wonder drug look like it just didn't beat out SOC Docetaxel, which it did and it beat out all historic MOS norms.