Shares of MannKind (MNKD) rise 4.3% premarket apparently in response to an SEC filing (8-K) which announces the publication of a series of FAQs (regarding the Affinity trial results) and responses from the company.
MNKD addresses the perceived discrepancy between the 0.4% change in HbA1c observed in Affinity 2 and the 0.5% change the original study design appeared to have called for the demonstrate superiority. There's nothing new here. The company says the 0.5% figure was related to the design of the trial and that the results were "extremely significant" — that's the same thing they said on the conference call.
Also addressed is Summer Street's now infamous "unprecedented" comment regarding data on the MedTone inhaler. MNKD says the performance of MedTone and the Gen2 device is "comparable" and, without mentioning any names, calls Summer Street's analysis "alarmist" and "subjective."