The 2nd CRL from FDA for Mannkind’s lead drug Afrezza hit the management and shareholders like a bolt of lightning. What is so sad is, the people with diabetes will have to endure 1-2 more years of needles. It appears that Mannkind was lead to believe that the in-vitro bioequivalence was enough. Later the FDA might have changed their mind and never informed Mannkind. It is also possible that FDA asked too many questions on Dreamboat and it prompted Mannkind to start Affinity2 trials in August 2010 time frame.
A new risk that has entered in the equation is the execution risk. To restore credibility in both FDA and Management & to create more transparency, I recommend the following
1) The entire Mannkind management should meet with all the divisions of the FDA. They have to take very careful notes.
2) Mannkind should get the CRL notes from FDA. They should not proceed with the new phase 3 trials till they get the notes. Let it take a week, a month, or a year. Mannkind should wait. As they say “assumption is the mother of all….”
3) The CRL notes should be published in a PR. The PR need not include confidential information, but information at a high level. All the shareholders & stakeholders should know exactly what FDA is asking for. A check list like a, b, c,…
4) Mannkind tasks/actions should be based off of the check list.
5) Mannkind management should solicit advice from ex-FDA directors
The FDA is only answerable to the US government and it reacts to the changing mandates and pressures of public. The way FDA thinks may not be in sync with what Mannkind management thinks or perceives. It is in the best interest of the shareholders that Mannkind’s thinking be in sync with FDA and not the other way around.
In 10 years from now, I hope to tell my kids that the 2nd CRL was just a minor hiccup in the glorious history of Mannkind. I have no doubt in my mind that if executed right, Afrezza will be a crowning achievement in the life of Alfred Mann.