MNKD drug will be approved and will be a blockbuster plain and simple
MNKD would have been approved last FDA NDA run through, if they had chosen to stay with larger inhaler.m they took chance filing with news baler and lost. FDA required two phase III trials to be ran with new inhaler for both type I and II Diabetics. Both trials are complete, results being tabulated and will be made known somewhere in first two weeks of August. NDA will be filed with FDA in late sept/ early oct..approval is just about as much a slam dunk as you can have with any NDA.
As for it being a blockbuster, it is simple... $19 BI.LION spent on insulin annually by diabetics. What percent do you think would rather puff an inhaler, then jam a needle into themselves?
As for the repeated Exiubera comparison, it is just stupid. Exiubera failed because the inhaler was a foot long bong.. No one is going to carry around a monster sized bong all day, but they will carry a whistle sized inhaler in their pocket, as most asthmatics have done for decades.
If MNKD captures just 10% of the market they will have nearly $2 BILLION in annual sales and I think that 10% is just the tip of the iceberg.
We had a heck of a run up to 8. We had some profit taking and have now settled into $6.50 range, give or take a quarter. I would be extremely happy to form a base here for next push, which should start to really ramp up in about 2-3 weeks in anticipation of Q2 CC and two trial results. We have a ton of positive news in the pipeline... August we have trial results, sept/oct we have FDA NDA filing, and at any time we could see partnership announcement, which we know by previous CCs that they Are working on.