Fool me once, shame on you; fool me twice, shame on me; fool me thrice, hit the sell button.
OK, so I just made up that last part, but yesterday, Protalix BioTherapeutics'
You'll recall -- or maybe not, considering how long ago it was -- that almost two years ago, the FDA asked Protalix and marketing partner Pfizer
After the duo submitted a second marketing application, the FDA set a goal of making an approval decision by Feb. 1. Unfortunately, the agency asked for more clinical data during the second review, and decided it needed until May 1 to make a decision.
Orphan drugs have become a lucrative business as BioMarin Pharmaceutical
Protalix uses plant cells to manufacture the drug. The novelty has its advantages, lower costs among others, but the novelty seems to be coming with added scrutiny from the FDA. Since the manufacturing side tends to be a black box for investors, it's difficult to assess the risk of another rejection.
The delay could be nothing. It could be the last one. This could be an excellent entry point. But "coulds" aren't very reassuring. Unfortunately, there's just no way to know if Protalix has finally submitted enough data to convince the FDA to approve taliglucerase alfa.