April 1, the April Fool's day. What an irony for MannKind (MNKD), a biotech company that asks the FDA to review its diabetes drug, Afrezza, at the FDA advisory committee (called Adcom). The Adcom is scheduled on April 1, 2 weeks from now. Can Mannkind survive this judgement on the April Fool's day? I highly doubt!
Afrezza is inhaled, rapid-acting insulin, used to be considered revolutionary. Insulin is in high demand and widely and frequently used among diabetic patients but until now it can only be injected, a painful formulation. MannKind invented an inhaled formulation and if successful, it would be a huge blockbuster with no question. It was so appealing that the world No 1 pharma, Pfizer, licensed in this product, trying to bring it to market. Unfortunately it failed and Pfizer returned it back to MannKind. Now MannKind has still not given up and it is trying to make it work by itself. They did a phase III study, but you know what? The study only involved about 170 patients, a tiny study population size in a final stage study!! This is just beyond me to understand how they could come up with this idea to do such a so-called phase 3 study to convince the FDA that this drug is working just fine.
I bet the Adcom won't recommend to approve Afrezza and MNKD will drop like a stone. So far MNKD is trading around $5 and it may plunge to $1-2 if it fails. If you are a risk taker and want to "gamble", this is a good opportunity to test your luck. Buying some MNKD put options can limit your risk but if you win, it can be substantial. But be clear, this is purely speculative, although the chance of win is high, in my mind.
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