Replies to post #82248 on Biotech Values

[drbio45]

this is a greater diservice. who at the fda recieved a paper bag with five million dollars to approve Vanda's drug?


One other Vanda related question -- who is the mystery "regulatory consultant" paid $5 million by Vanda for his assistance in getting Fanapt approved by the FDA?

Vanda, Oculus, Sequenom: Biotech Notebook
Adam Feuerstein
08/11/09 - 07:00 AM EDT
BOSTON, Mass. (TheStreet) -- Vanda Pharmaceuticals' (VNDA Quote) buyout partner remains missing in action. No more improper drug marketing claims from Oculus Innovative Sciences (OCLS Quote). Sequenom (SQNM Quote) walks back expectations for its Downs syndrome gene test -- these are some of the random notes and observations from second-quarter earnings.


Vanda Pharmaceuticals
Vanda reported a higher-than-expected loss for the second quarter Monday, but it's what the company didn't report -- a buyout or marketing partnership for its schizophrenia drug Fanapt -- which disappointed investors the most.

Three months have passed since the U.S. Food and Drug Administration's approval of Fanapt surprised everyone (including Vanda, from what I hear), yet the company seems no closer to launching the drug.

Vanda bulls are hoping the company is acquired outright, or at the very least, Vanda manages to license Fanapt to a larger drug company in exchange for a hefty sales-based royalty. Monday, however, the company said it was still evaluating all its options, which includes launching the drug on its own.

Vanda CEO Mihael Polymeropoulos said Monday that the company's plan is to have Fanapt available to patients in the fourth quarter. Yet if Vanda tries to sell Fanapt on its own, the stock will get crushed.

One other Vanda related question -- who is the mystery "regulatory consultant" paid $5 million by Vanda for his assistance in getting Fanapt approved by the FDA?

Vanda shares closed down 10.2% to $13.93 on Monday.

[DewDiligence]

Sadly, it also adds to a large body of evidence that many long-time FDA employees wouldn't see the appearance of conflict of interest if it co-authored a journal article with them. They do the rest of the Agency a grave disservice in the public arena.

What should the FDA have done differently, IYO, in the way it went about solving the contaminated-heparin problem? Would it have made any consequential difference if Dr. Woodcock and other FDA staffers had omitted their names from the published papers describing the scientific process by which the integrity of the heparin supply was restored?

[Biowatch]

Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta's founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts were their attendance at an international medical conference in Thailand in November 2007.

Do you suggest that FDA employees avoid any medical conference that MIT professors or biotech/pharma scientists attend?

i.e.., Forget ASCO, ASH, or any meeting listed in the Scientific Calendar... #msg-39729635

That seems extreme...