Rodman & Renshaw believes the FDA issued MannKind the good kind of complete response letter as the issues brought up can be addressed without significant delays. The firm reiterates its positive call on the stock and maintains an Outperform rating on shares with an $18 price target
Mandkind claims that the Dreamboat device uses 1/3 less powder than the Medtone. Why would management expect the FDA to approve the Dreamboat without the same level of testing (clinical trials)as the Medtone?
This would be the same as a company testing a 100 mg. dose of a drug for three years and then requesting that the FDA approve a 65 mg. dose.
Is Mannkind's management really that in incompetent? Do they think the FDA is that stupid?