But exceptions can be made when a company, even one that little, has real news.
Out of nowhere late Wednesday the FDA approved VNDA's schizophrenia drug with the funky name Fanapt. I've gotta hand it to Adam Feuerstein at TheStreet.com on this one. He summarized the shock and awe of the situation when he wrote, "Hell froze over Wednesday night, right before a squadron of flying pigs took to the sky." Nice write, dude.
Vanda's M-O is to take other drug companies' trash in hopes of turning it into treasure. But the business model wasn't working out so well. The FDA had given Vanda what's called a "non-approvable" letter. That almost always means the drug is pretty much dead in the water. One major investor was pushing the company to fuggedaboutit.
VNDA became a penny stock.
I had once covered the company for awhile a couple or three years ago when it looked like it had something going on. We even had the CEO on live once or twice when I had to rehearse his name, Mihael Polymeropoulos, over and over and over to make sure I didn't mess it up on TV.
In this case, drug giant Novartis (NVS) used to own the Fanapt, but unloaded it. NVS will still get a royalty on sales, but in an exclusive interview on CNBC's "Squawk on the Street" Thursday morning, I asked the Swiss drugmaker's Chairman and CEO, Dr. Daniel Vasella (yes, he's an M.D. who specialized in psychosomatic illness), if he had seller's regret.
Is this a one-off or, to use an overworked term these days, a green shoot sprouting at the previously very stingy FDA? Natixis Bleichroeder analyst Corey Davis is one of the few analysts who was still covering the left-for-dead company. He writes in a research note to clients, "In one of the most surprising moves we've seen out of the FDA this year, the agency did a complete about face on Vanda's (Fanapt) and gave it outright approval. Perhaps the presence of a new commissioner is already having an effect." Davis, by the way, has to be a happy camper because he owns VNDA shares. And his firm makes a market in the stock.
I think it's too early to call this the dawn of a new day at the FDA. But when hell freezes over and pigs fly, who knows?