FDA requesting cardiovascular safety studies from some diabetes drug makers
Look who is NOT on the list. I guess MNKD's statement on the last call that they believe they meet the FDA draft guidelines is true. Not surprising as this company does not make statements to shareholders unless they have a high degree of confidence that they are accurate.
If there were a letter, we would have heard about it. Otherwise, I think you need to rely on the Company's assertion that they believe they meet the FDA draft guidelines. By the way, the IR contact I have dealt with is Roberta Dey. She has forwarded my questions to the appropriate people, and I have always received timely responses.
If you read the transcript of the last CC, Dr Richardson talks about the extensive cardiovascular safety studies they have done. I have to give them the benefit of the doubt when they say they meet the guidelines as they have always been careful about promises they make to shareholders. Also, I believe all drugs that are getting notices are non-insulin based.