Replies to post #40777 on Cel Sci Corporation (CVM)

[Henkel]

He said peer review and preBLA would happen simultaneously

[G8TSTFL]

So Cel-Sci thinks having their data published in a scholarly, peer-reviewed journal will get them over the finish line with the FDA.

The FDA will not be able to make a determination if the data is sufficient to approve without non-FDA medical experts opinions. If this is true, why do we need a bloated, over paid federal arm, that bottle necks drug approval to the point of absurdly?

Just have the prestigious privately owned clinical journals decide if a drug is approvable. Boom, we just saved millions, if not billions of dollars. They can’t be any more corrupt or obviously incompetent as the FDA regulators who can’t make independent decisions.

I’m sure many are thinking, Dude, this is just the way the game is played.
Yet another reason the Federal Gov’t needs to be broken down to its bare bones, similar to what the founders had invisioned.