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Biotech / Medical : LCI - Lannett Company, Inc.

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From: demersal6/5/2011 8:21:30 PM
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The real issue with this stock is the lengthy delays by the FDA to make a decision one way or the other in regards to its 3+ pending applications, including the big sulfate application. The expected decision by the FDA is already passed. It's really an "any time now" type of scenario. The FDA obviously doesn't think this is an urgent application; so whenever they get around to making a decision, they will.

I personally think that because the sulfate application is a pretty generic application (for which there are already existing, competing products in the market), there is not a huge risk of outright rejection for the drug. However, you know how the FDA goes in terms of wanting "revisions" and "more data" and the like.

Expect a decision very soon. Positive or negative, I have no idea.
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