Mo_Money has a good post over on the Investor Village board:
MNKD Piper Jaffray Q&A Session
I would encourage everyone to listen to the Piper Jaffray conference MNKD participated in on the 27th. Hakan did a nice job and it was a Q&A format.
As of 11/27, all of the trials are now full and they expect the final dosing between the 3rd week of May to the 1st week of June.
Top line results will be in early August, giving those who want to take a long position many months to build a position on pullbacks.
It is MNKD's view that the FDA is looking for a way to use Afrezza as a way to introduce insulin earlier in the treatment cycle. As longs know, this is key and will lead to Afrezza being a multi-billion dollar a year product, and quit quickly (once additional manufacturing capacity is added.)
The trials underway is exactly what the FDA wants to see based on multiple face to face meetings with them, including going to an earlier stage in the disease progression (to me this is the difference between Afrezza being a $1B drug vs a $5B drug within a few years of approval.) 22 people from the FDA participated in these discussions, including Mary Parks!
FDA did not demand rigorous pulmonary testing on these trials, which read into it what you may but the short thesis here commonly referred to pulmonary concerns...
Partnership: Maintenance discussions but don't look for discussions to heat up until they have the data from the studies mid 2013. I personally don't think they do anything until after approval and final label. And rather than partner though, I think they get bought out in the 2nd half of 2014... (just my opinion of course.)
Financing: Next October, when they are close to running out of money, if the 171/175 results are good, they expect the warrants to be exercised. That and the available credit line will see them well through approval. My read is MNKD expects share price appreciation with good trial results...
Pricing: The partner will set but they expect it will be no more than a single digit premium above existing rapid acting insulin. (last I checked, Lantus is around $120 per vial and patients generally use 1-2 vials per month, plus the cost of syringes. So I would guess that Afrezza would cost around $120 for an equivalent number of units as a vial of RAA so probably looking at $120-240/mo per patient.)
Also, it is worth mentioning that Afrezza is also likely to be treated as a new chemical entity.
Between now and August, MNKD is highly likely to remain range bound, with low volume and stay likely under $3. For me personally, I will be adding to a full target position by July. I think the risk / reward profile, especially under $3, is compelling as a long-term hold.
