Taliglucerase alpha was up for approval two years ago, but the decision was delayed because the FDA wanted more information on the manufacturing process for the drug, which is made in plant cells rather than the more traditional mammalian cells. Eventually, the FDA rejected the drug, requesting clinical data on the switchover trial and other information about how it tests the drug to make sure it's been produced correctly.
I hate these types of binary events. There are too many unknowns with manufacturing issues to feel confident about an approval. Discovery Laboratories
And it's not as if the FDA is likely to be lenient just because Gaucher disease is rare. The FDA turned down ViroPharma's
Protalix says it's answered all the FDA's questions, and I have no reason to think otherwise. But investors have very little insight into what the FDA is thinking about the manufacturing issues. I hope taliglucerase alpha is approved, but given the unknowns, I don't see how it's worth placing a big bet on the agency's decision.
Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Pfizer. The Motley Fool has a disclosure policy.We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.
More from The Motley Fool
3 Dividend Stocks That Pay You More Than ExxonMobil Does
The oil giant pays its shareholders well, but there are opportunities out there for even higher payouts.
The 1 Word That Explains Why Pfizer's Future Looks Brighter Than Its Past
The big drugmaker had a clear message at the J.P. Morgan Healthcare Conference -- and it's a good one for investors.
3 Scorching-Hot Healthcare Stocks -- Are They Buys?
These three companies gained at least 400% in 2017. Can the good times continue?