MannKind Corporation (NASDAQ: MNKD) is a true cult stock in biotech with FDA communication and many skeptics over how safe or effective its product candidate is. Shares are trading higher this morning on news that the company has re-submitted its new drug application for AFREZZA and classified it as a Class 2 resubmission. The company also noted that the FDA accepted the resubmission.
The FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.
The FDA’s Complete Response Letter issued back in March had requested additional information from MannKind regarding AFREZZA. In the re-submission,the company says that it has provided clinical data from a recently completed efficacy study in patients with type 1 diabetes, The company also noted that it has provided an updated pooled safety data related to AFREZZA and information on the comparability of its delivery system used in pivotal clinical studies.
MannKind is not without its share of controversy. The inhaled insulin market is one that has never been fully developed because efficacy and safety issues elsewhere. Some critics blame the poor performance of predecessors while others blame MannKind for its own woes. The short interest below should show just how much controversy there is around MannKind:
- 6/30/2010 had S.I. of 17,236,299 shares.
- 6/15/2010 had S.I. of 16,753,981 shares.
- 5/28/2010 had S.I. of 15,357,935 shares.
- 5/14/2010 had S.I. of 15,107,662 shares.
So far we have shares up almost 9% at $6.76 on almost 700,000 shares as of 9:45 AM EST.
JON C. OGG
