From the Griffin report:
"New clinical trials of Afrezza® should support its launch for most patients with either
type 1 or type 2 diabetes in 2013. The final pivotal trial has begun to enroll type 1 diabetes
patients to satisfy the FDA’s demand for a clinical comparison of a new inhaler and an earlier
version. The other study is designed to expand the market for Afrezza to type 2 diabetics who
are not adequately controlled by one or two oral therapies. Favorable results would position
the drug to compete in virtually the entire diabetes market."
OK, so now we're talking about the whole shebang- all diabetics. This triples the potential market that existed at CRL2.
90% of diabetics are T2, but only 25% use insulin. If we're going after the entire diabetes population, not just the ones already using insulin, this triples the market that was factored into the 2nd NDA. At that time, MNKD was valued at 1 B. So now the valuation should be 3 B.
3 B / 280 M existing shares = 10.7 share price
3 B / 550 M potential shares = 5.5 share price
These are just the possible valuations running up into the PDUFA over the next year or so.
