Anavex Life Sciences Corp (AVXL)

[abew4me]

There's plenty of reasons not to file with the FDA. I follow a few investment newsletters and Ray Blanco has a pretty good record...but one of his recommendations was turned down by the FDA even though their P3 was successful. (See below)

Time to Exit This Play On Disappointing FDA News

The news hasn’t been so good for Actinium Pharmaceuticals (NASDAQ: ATNM). The company was gearing up to submit an application to the FDA for its Iomab-B radiotherapy.

The FDA, however, wants more data, and will not accept the company’s completed Phase 3 trial for Iomab-B acute myeloid leukemia, even though the drug was a great success in achieving its primary endpoint in preparing patients for a bone marrow transplant.

Actinium is going to have to run an entire Phase 3 trial all over again, with a head-to-head matchup against existing therapies for the FDA to consider the drug for approval.

[And yes. I realize that we can easily beat the SOC in a head-to-head match up. But I don't trust the FDA because they can come up with plenty of other excuses to protect BP mabs.]

ATNM shares got clobbered on the news. The company says it will have to seek a partner to further develop Iomab-B and get it to the FDA.

It’s time to throw in the towel on ATNM and move on to other plays with better near-term upside.