I started a small position in MNKD after a recommendation on the GNW board, doing some DD, and listening to the Morgan conference - but I have a question/concern.
AT 00:24:00 in the conference (if you want to listen)... (Paraphrasing) Mr. Mann mentions a Regulatory concern that MNKD has asked the FDA to accept/approve a 3rd device (from the one used in the original trial) - But MNKD has not heard from the FDA and MKND go to market strategy won't be resolved until this newer, "more efficient" device has been vetted and approved by the FDA.
Why is everyone so suspicious, paranoid and borderline hateful around here? This stock is about to explode and make everyone a lot of $ and people continuously attack those with contrary opinions or people who ask what seem to me legitimate questions.
Nobody is paranoid here,but suspicious for a good reason.!!!When you make $100K profit on one stock-and keep going up, why he is interesting stocks which is on the 52 weeks high?????? He didn't care MNKD when traded at $2 or $3.The bashers here have 6 or more ID names and twisting MNKD future as a "long".
He is basically saying that they prefer to launch with the Dreamboat inhaler, if that wouldn't delay the launch too much.
My guess is that the FDA will accept MNKD's proposal for a 3 month bio-equivalency study which means it can be added to the current NDA and delay would be minimal (a few weeks, up to a few months max).
However if the FDA requires a longer study they might make it part of a new NDA and launch with the old inhaler instead. That is less desirable but also less likely to occur. Mannkind is pretty thorough in it's trials. Their proposal might even be more then what the FDA strictly requires.
This issue was discussed before on this board, I think a month or two ago. Al is just confirming what we were speculating on back then.
Let me be clear-they said that the potential partner wanted to launch with the Dreamboat..but if FDA approves they are going with the already approved version until Dreamboat is approved..there is no delay in launch! It is only a question of if they can pull in the Dream boat to launch with because the potential partner would like to launch with it so the company is making that effort..but this has already been discussed!! NO DELAY!