- In its statement, MannKind says FDA asked for "information and currently available clinical data that support the clinical utility of Afrezza."
emphasis added.What does "clinical utility" mean? Is the FDA questioning the clinical need for an inhaled insulin device to treat diabetics, and therefore wants MannKind to justify Afrezza's utility? Such a request by FDA isn't a particularly optimistic sign for Afrezza's eventual approval. The agency commonly questions the efficacy and safety of a medical device or drug, but I'm not sure I can recall a situation where FDA wants a company to defend the need or utility for a device or drug. Perhaps this is a semantics question, but it's one that MannKind should clear up Tuesday.
- According to MannKind, the FDAs complete response letter "did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA."
Emphasis added.The FDA not asking for new clinical trials as a pre-condition for approval is usually a good thing, but is that what Mannkind is really saying here? The company's statement says FDA didn't ask for new trials to "complete" its Afrezza review, but is that the same thing as saying FDA didn't ask for new trials in order to approve the device? Again, this might be picking semantic nits, but check out how Cadence Pharmaceuticals (CADX) described on Feb. 11 the FDA complete response letter received for its experimental intravenous acetaminophen: "The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval." Definitely different wording. Different meaning?
- In January, MannKind said that the FDA was forced to delay its Afrezza review because the agency had not completed an inspection of a third-party manufacturing plant in Europe that makes the insulin used in the device. Yet Monday, MannKind's statement says nothing about the status of this inspection holdup.
- Mannkind says it plans to schedule a meeting with FDA to review the Complete Response Letter. The company doesn't say when that meeting will take place, nor does the company offer any specific timelines about resubmitting requested information to the FDA. Even under generous assumptions, it doesn't seem like FDA could be in a position to approve Afrezza before 2011. MannKind, on its call tomorrow, should provide an updated regulatory timelines, even a rough guess, given that the expectations are for Afrezza to be approved this year.