|Shares Out. (in M):||50||P/E||0||0|
|Market Cap (in $M):||108||P/FCF||0||0|
|Net Debt (in $M):||30||EBIT||0||0|
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Below we further explore a fact base that points to a very high likelihood of approval. If our assessment is correct then CORV stock is a highly compelling with material near term upside. We will try to keep things as simple as possible but are glad to engage in more detailed conversations. In addition, we are very eager to hear from investors who think we are incorrect in our assessment of the approval probability.
Brinavess nearly got approved in 2007 in the United States. In fact, the FDA Adcom voted 6-2 in favor of approval. Depending on analysis – for new drugs the FDA typically follows the recommendation of the Advisory Committee about 85% of the time.
Despite the positive Adcom in 2007 the FDA did not recommend Brinavess for approval. It was their concern (and the concern of the two dissenting Committee members) that the safety profile of Brinavess was not yet fully understood given the available data.
One contributing factor was the death of a South American patient who received Brinavess as part of a clinical trial. This Serious Adverse Event (SAE) created concern. There has been much debate about this patient and whether he even met the criteria for the study and what he actually died of – but, either way this single event was a contributor in the non-approval of Brinavess.
When it comes to the PDUFA date and to the final decision we think the FDA will be asking themselves one question. Is the drug safe? They knew it worked in 2007 and subsequent data is confirmatory – efficacy is not the question. Safety is what will govern their decision. Now that they have a large study (Spectrum) and lots of other studies to rely on – the FDA should be comfortable in answering the safety question.
Why do we believe CORV will ultimately sell? Mostly because commentary from management does not indicate building a sales force and taking Brinavess to market alon...or suggest running Correvio as a long term, independent public company. (listen to management calls and conference presentations).
- Sale of the company
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