I know a great many of the Irregulars have been interested in FDA dates recently, partly thanks to the community of biotech enthusiasts who have coalesced around the musings of our own Dr. KSS, so I thought I’d spin out a quick answer to you for a teaser pitch that’s been sent out quite breathlessly in recent days.
The teaser pitch is for Ernie Tremblay’s Bioscience Millionaire, which is a very new letter that we wrote about last month when they first started promoting themselves, and they’ve built up the letter to be almost like an alert service revolving around the “Most Profitable Calendar Known to Man” … basically, ideas about biotech stocks that you can trade which are expected to release results from trials soon, have advisory committee meetings with the FDA, or, arguably most importantly, that have PDUFA dates coming up soon.
(PDUFA dates are the dates by which the FDA is supposed to respond to New Drug Applications (NDA’s), they were added to the FDA’s regulatory framework to add more specificity and predictability to the FDA approval process … in exchange for the user fees that pharma companies now have to pay. PDUFA stands for Prescription Drug User Fee Act.)
The first ad for Tremblay’s letter touted three stocks with upcoming key dates, Durata Therapeutics (DRTX), Nektar Therapeutics (NKTR), and Pozen (POZN). POZN’s “date” was in late April and didn’t do much for shareholders — I haven’t looked into the details but it looks like their drug was rejected but not necessarily for safety or efficacy (something to do with one of their active ingredient suppliers, you can see the short Motley Fool response here) — Durata has been talked up quite a bit here in Gumshoeland after Dr. KSS looked into it in detail a few weeks ago, but their FDA response hasn’t come yet (due within a week now), Nektar was a “date” off into the Fall.
This one talks up an entirely different stock (and drug) — here’s how they tease it:
“Top Hedge Fund Manager Announces $130 Million Buy of a Tiny Company We’ve Been Following For 7 Months…
“Why did one of the world’s most respected and successful investors…
“Who was recently ranked the one of the best-performing hedge fund managers of all time…
“… who warned of a looming stock market bubble in a private letter to clients…
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