It's the binary news events -- clinical trial results and Food and Drug Administration approvals -- that make drug developers so fun to invest in, and so hard to stomach ... sometimes all at the same time. Let's take a look at a few companies expecting FDA decisions this month.
Johnson & Johnson
While approval of the immediate-release version of tapentadol will certainly produce sales, a long-lasting extended-release version is more likely to deaden the pain associated with the cost of development. That's because it'll be more convenient for patients than the four-to-six-hour dosing the immediate-release version requires.
Bigger is better
The interesting thing about this decision is that it has far-reaching consequences beyond Genzyme's one drug. Generic-drug companies like Novartis
Getting back to Myozyme, I think it's likely that the FDA will compromise and approve manufacturing of the drug, but only for adults, leaving the more proven smaller scale available for children until the larger scale is proven effective. With a PDUFA date of Nov. 29 -- the Saturday after Thanksgiving -- it wouldn't surprise me to see Genzyme getting its gross-margin stuffing a little early this year.
As one of the first benefits from acquiring MedImmune's pipeline last year, AstraZeneca
Motavizumab should also help AstraZeneca stay ahead of Alnylam
Perhaps this article is 90 days too early
It's important to remember that these dates are goals that the FDA sets for itself. Recently, the agency has been missing those targets left and right. Sometimes the delays are announced ahead of time -- Ligand Pharmaceuticals' and Pfizer's
For day traders, that's got to be disappointing, but for Fools it doesn't matter all that much. Pick a good price, assume a delay is inevitable, and confirm that the company has enough cash to deal with the delay. Then sit back and enjoy the gut-wrenching show.