Replies to post #40783 on Cel Sci Corporation (CVM)

[Henkel]

You really think you know what Geert and his staff of experienced employees and consultants are thinking? I bet he wishes he had some message board gamblers on his payroll.

This is a solid point: Yet another reason the Federal Gov’t needs to be broken down to its bare bones, similar to what the founders had invisioned.

[Dr. Johnny Fever]

Well, Henkel raised a good point- Geert has said that publication and peer-review will happen simultaneously. So I stand corrected there. However, CVM is not the entity with the power here – they can’t very well tell a publication when to publish, or tell the FDA when to have a pre-BLA meeting, unless the FDA has given its blessing to proceed with a pre-BLA meeting once CVM is ready, meaning once CVM knows it’s trial data is about to be published. This is, as you say, how the game is played, and the FDA knows the company wants a guarantee that the trial data has been accepted for publication prior to a meeting that they’ll have to tell investors about. They may be able to arrange for the two to happen at or about the same time, but it’s not publication in a peer-reviewed journal that determines whether or not they can get MK approved. They want the publication at, or just before, the pre-BLA meeting for a number of reasons: having a publication in a peer-reviewed journal adds tremendous credit to their work; their scientists win acclaim for their efforts from the science community; publication in such a journal guarantees that the trial data has heavily and objectively scrutinized by other experts who are not associated with CVM; doctors who will want to consider prescribing the treatment will look for such a publication in their research before deciding to recommend it to their patients; publication will make MK a more-attractive target for acquisition; etc., etc. Given the apparent hoops CVM must jump through in the publication process [see quote in my previous comment] it’s likely that they are simply waiting for word that they’re getting published before moving forward with pre-BLA.

[exwannabe]

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 could care less about a peer reviewed paper.

A Pre-BLA meeting will not make a decision as to the approval, it will make some opinions on if there is sufficient information in all areas to make a filing worthy of review. They will look at far more than a per reviewed paper does. Pre-clinical data, manufacturing and other issues.

When it comes to actual approval time, the FDA looks at the actual data, not just the summary presented in a paper.

There have been cases (I know of at least two) where peer reviewed papers were published saying how wonderful the drug was. And the FDA CRL'd it because people who took the drug died faster than those who did not.

BTW, most small biotechs announce the Pre-BLA meeting and other step prior to trial results being published.