Mannkind (MNKD) was set to meet with the FDA this week, a re-scheduled event after having the meeting cancelled last month when it looked like the U.S. government was on the verge of a shutdown, but shareholders have yet to hear about what took place during the sit-down.
The meeting between Mannkind and officials from the regulatory body was a chance for the company to discuss the FDA's denial of approval for the inhaled insulin spray Afrezza, which was announced in January, and to identify a plan for moving the product forward to market.
According to information published at the time of the denial, the FDA wanted to see proof that Mannkind's next-generation inhaler worked as well as the inhaler used during the already-completed late stage trials.
It looked like, at least at that point, that Mannkind would certainly need to conduct additional trials and get that information to the FDA before approval would again be considered.
The bottom dropped out of shares of MNKD at that point, and even further when the company shaved over 40% of its workforce in an effort to reduce costs and streamline resources towards an eventual Afrezza approval.
However, even with the setbacks, the potential for an eventual Afrezza approval never wavered.
Some have even speculated that the FDA would decide to conditionally approve Afrezza with the inhaler used during the trials while the company continued testing with the next-generation inhaler.
The meeting with the FDA should have already taken place, so we'll know soon enough as to what went on behind closed doors.
Additional speculation has Mannkind announcing a partnership or an outright buyout on or before the date of the May 9th scheduled conference call. CEO, founder and Afrezza financier supreme Alfred Mann has alluded to those possibilities in the recent past, which only fuels the speculative fire.
That said, one would think that Mr. Mann would want a significant return-on-investment for his near-billion dollar support for his company, which may limit any potential deals at this time due to the sharp premium an offer would have to entail.
The company's entire market cap is roughly half of what Mr. Mann has invested in it, but the potential of an inhaled insulin spray on the market could be valued at many times more than the current MNKD market cap in a buyout offer.
Also on the insulin-spray radar is Generex (OTCQB:GNBT). Generex is currently awaiting word from the FDA regarding whether or not the company should proceed with filing for Oral-lyn approval even though the Phase III trial did not enroll as many patients as originally intended.
With both companies waiting on the FDA, it looks like the FDA is going to play a major role in which company can get its product to market first.
Due to the potential of either Afrezza or Oral-lyn on the market, which could revolutionize the delivery of insulin to diabetics by eliminated the need for the needle, both companies could be significant bargains at the current time.
Both at least are worth a look, in my opinion, as both may have partnerships announced before too long.
Mannkind has been silent thus far this week, but investors should have some answers by the conference call on Monday.