MNKD - from last week:
Mannkind: Color on Quarter (5.30 ) : Rodman and Renshaw note last night MNKD reported 3Q09 financial results. They note investors' focus remained on the upcoming FDA decision on the Afresa NDA, which has a January 16, 2010 PDUFA date. The co announced during the call it was told by the FDA that the Afresa NDA "did not need to go in front of an advisory panel". The co is currently anticipating that the agency will be able to render a decision by the PDUFA date, and was not expecting any delays. They are as bullish as ever on Afresa and MNKD, They continue to believe that Afresa should not be bundled together with Exubera et al.; but that it is a "better" insulin, they like Afresa's chances for a positive outcome from the FDA in the spring (straight approval or a CRL with minimal requirements that can be addressed within 2010), and that the co will be able to secure a worldwide partnership for Afresa following FDA approval that has the potential to become a multi-bln dollar drug/device combination... Leerink Swann continues to believe that Afresa is a differentiated insulin which should obtain approval, but predicting timing of FDA decisions is always difficult and commercialization may be a tough task without a deep-pocketed partner. The Afresa PDUFA date is binary and shares could trade up meaningfully if approved in a timely fashion. |
