this should run to at least 3 before phase 3 results
and spike to 5 with settle price of 3.5- 4 there after with good results
then gets bid to 7-9 range before approval
and spikes to 13-15 with settle range of 10-13 on approval
no approval = $0-$0.5
60% odds of approval and make 600% and 40% chance lose it all
I will take the former
Per some other post - after a company has gone thru 2 CRL's - there is an 80% chance that approval will be made by FDA. The reason for the CRL's was due to results given on original MedTone device and then a follow-up with the Dreamboat device using less of AFZA(my abreviation), but with less patients used and not showing the difference between the two devices. New trials now in progress to show this and will show a positive efficacy of the drug.
Sentiment: Strong Buy
Both phase 3 trials should be completed in May with top line data available shortly thereafter. FDA submission will probably be by September. The review takes 6 months so the date for a decision on Afrezza is probably sometime in Q1 2014.
Partnership negotiations have been ongoing since at least 2009 with no results. Whether Al Mann is asking for too much because he thinks he has a mega-blockbuster or the potential big Pharma partners are spooked because of the Exubera failure and the unpredictability of the FDA, there is no deal imminent. At this point management seems to think they will be in a stronger position when they have the trial data in hand, so there will probably be no news before summer, if there ever is a deal.
The factory in Danbury, CT is projected to produce $2billion/year of Afrezza with 3 production lines, and Al Mann would claim that potential sales could top $10 billion/year, but without FDA approval or if there are other unforeseen problems, that number could be zero.
Management says that they had discussions with insurance providers and because Afrezza is projected to cost just 5-10% more than conventional insulin injections, it will be covered by most insurance.
MNKD has suspended work on all other projects because of financial constraints, and has formed partnerships with 2 smaller companies to develop their cancer drugs. The technosphere technology does seem very promising for delivery of a wide range of medicines, including pain medications where the research seems to still be ongoing.
In short high risk, and high reward if Afrezza is everything Al Mann claims and MNKD can get over the regulatory, financial and marketing hurdles.
Sentiment: Strong Buy
What specifically would you like to discuss? Not much to talk about, at least until top line data is released. Most of my time on this MB is spent placing #$%$ on ignore. Effectively all the quality posters left after the last CRL...