The PDUFA date for the FDA to make a decision is Jan. 30. That's a Sunday, so we'll likely hear on Friday or Monday or maybe even earlier. The PDUFA date is a goal; it's not set in stone when the agency will announce its decision.
Predicting the fate of DM-1796 seems easier than other recent FDA decisions. The drug is a long-lasting version of the extended-release formula of gabapentin, which Pfizer
That's in contrast to GlaxoSmithKline
There are also a couple of indirect signs that DM-1796 will get past the FDA.
On a conference call last week, an analyst asked if Abbott and Depomed were discussing the label with the agency. Since there's little reason to work out the details of the label if the agency is going to reject the drug, the analyst was really asking if it seemed likely that the agency would approve the drug. CEO Carl Pelzel wouldn't bite but did say that he was confident that the agency would make a decision by the PDUFA date. While that's not quite as satisfying, it's at least a sign the FDA isn't still shooting a lot of questions at Abbott and Deopmed.
Last week, Depomed said Abbott Labs
The last two are more conjecture than solid investment theses, but with the black box FDA, that's about all you're going to get.
What do you think? Take our Foolish poll and fill in your reasoning in the comment box below.
Pfizer is a Motley Fool Inside Value recommendation. GlaxoSmithKline is a Motley Fool Global Gains recommendation. The Fool owns shares of GlaxoSmithKline. Motley Fool Alpha owns shares of Abbott Laboratories. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.
More from The Motley Fool
Why 2017 Was a Year to Forget for Pfizer Inc.
Pfizer's 2017 wasn't horrible. Just ho-hum.
3 Dividend Stocks to Buy on Sale
It's hard to go wrong with high dividend yields, low earnings multiples, and solid long-term business prospects.
3 Dividend Stocks Perfect for Retirees
Step right up and collect your income!