The meeting provided investors with recorded Adcom testimonies from trial patients that were very compelling and likely never seen before by many investors.
MannKind directors responded very positively to the concerns raised regarding cancer risk, and clearly noted there were no extraordinary events seen in the trials.
In direct response to another CRL concern from a shareholder, the COO stated that they are done with CRLs and the company was well underway.
Al Mann discussed the unlimited possibilities of the Technosphere platform, and gave a very compelling pain management scenario.
MannKind Corporation (NASDAQ:MNKD) held its annual shareholder meeting last week on May 22, 2014, at the company's Valencia, CA headquarters. The meeting was more than just the standard proxy and vote session that shareholders are accustomed to seeing at some shareholder meetings. In fact, one of the most compelling agendas of the meeting was the playing of the recorded video of real-life Afrezza trial patients presenting their testimony to the FDA Advisory Committee (Adcom) panel on April 1, 2014.
Video of Trial Patient Testimonies
The testimony of trial patients provided to the Adcom panel were true life accounts surrounding those who spend every day of their lives trying to manage their diabetes. Several of the trial patients described how hard it was to manage their condition with current methods. They also spoke about the damage to their bodies that the use of needles has caused, and the quality of life and suffering they have had to endure from using traditional treatment methods. Every patient spoke about the ease of use and improved management of their diabetes while using Afrezza. One trial patient even stated that his only regret since the trials ended has been that lack of the ability to continue use of Afrezza. Each patient also noted the lack of any negative effects to their bodies and lives while participating in the trials. There is no doubt that the quality of life improvement that Afrezza provides to diabetic patients was a very key proponent to those who testified, and this testimony was no doubt a big factor in the FDA panel's recommendation for approval, just as it should have been. As several of the trial patients noted, there is so much more to Afrezza than just the data.
It is likely that many investors and other diabetic patients have not seen this testimony to the Adcom panel by these trial patients, and I fully believe that every person should take the time to watch these patients give their testimony and hear what they had to say.
For current and potential investors of MannKind, and future potential users of MannKind products, the Q&A session provided at the end of the meeting was very informative. Company directors were able to provide a little more personalization in regards to how the regulatory process is going with the FDA. Below are some of the questions from attendees, and summarized/quoted answers provided by company directors.
Question #1 from Attendee
"One of the last concerns from the Adcom was in regards to cancer risk. I know in your trials it shows no risk of lung cancer, could you show a little more color on that issue. How much lung cancer have you seen, or is it out of line with the normal population?"
Al Mann, chairman of the board and CEO, answered this question directly and noted "What MannKind has seen is quite in line with the normal population, and there were no extraordinary events seen in the trials". He advised how the physicians are much keener to follow up each and every sign brought to them by patients during new product trials, and that you get a much greater scrutiny during new drug trials. He noted that senior experts are always concerned about risk. More importantly, he specifically noted, "We (speaking about Afrezza) are only in the lung for a very few minutes. After a couple hours, there is very little trace of the drug in the lungs." Equally important, they saw no effects to lung tissue in any of the trials.
Questions #2 from Attendee
"What is the status of the inspection of the Danbury facility?"
The directors noted that the regional agency was in the facility last year. One director noted, "There are no findings since that inspection, and they do not expect any issues in the regulatory process." The directors stated they are shooting to be technically operational by the end of the year for production. They have brought systems back into commission. They are running demo batches constantly. They have new innovation, and they are currently doing test runs and dry runs to detect any issues. They are developing SOPs and hiring staff. They are in the process of "building people and production capacity to be ready to launch on approval."
Question #3 from Attendee
"What are the other applications of the Technosphere platform, and what is Al's vision?"
In a very upbeat manner, Al Mann quickly stated, "The process offers a very very powerful way to deliver a drug very quickly into the blood and stabilize drugs that are not stable enough to deliver through many other technologies. A drug delivered for migraine headache now takes about an hour for a person to become comfortable. Imagine being able to deliver it (pain management medication) in 2 to 3 to 4 minutes and having freedom from a migraine. Wouldn't that be a big improvement? There are a lot of opportunities… But we have to concentrate first on getting Afrezza to market." President and COO Hakan Edstrom went on further to say, "We are looking at all organizations to get Afrezza to market on a global basis, and our vision is to create a MannKind Development Corp. as well, which would exploit the platform to other applications. There are a number of opportunities."
Question #4 from Attendee
"40 days after the Adcom, what is the interaction between the FDA and MannKind? Are you getting any signals? What is going on? Are you going to get another CRL?"
Mr. Edstrom immediately responded, "We are getting a lot more than signals. We are exchanging a lot of information. The exchanges are very open, professional, cordial, and keen to moving the process forward." In adamant fashion, Mr. Edstrom said, "We are done with CRLs. We are certainly not expecting that. We just had a very good conference call last week with the agency, and we are confident that we are well on our way."
Question #6 from Attendee
"Do you see MannKind at a state where you would you be open to selling MannKind?"
Al Mann answered, "I can't really answer that. I have never gone around trying to sell my earlier companies; people have always come to us wanting to buy them. We have not considered trying to market the company (MannKind), and I don't think we will. If someone wants to acquire us and make an offer that will benefit patients and shareholders, then we ought to take a look at it."
Even though there were a few other questions asked, I have only identified the questions that I believe provide shareholders and patients further optimism of the FDA approving Afrezza. The directors appear to be very upbeat and confident regarding the chances of approval this time around. The live testimony of trial patients at the Adcom gave the panel a real opportunity to see all the benefits of Afrezza in their lives, outside of just the data. I believe the testimony and the trial data presented to the FDA clearly shows a clear benefit and an increasing demand from patients wanting new and better ways to manage their disease. I strongly believe Afrezza is one of these options, and the Technosphere platform will revolutionize delivery of fast-acting drugs into the body going forward. I also believe the days of using needles will gradually coming to an end in the future.
Disclosure: I am long MNKD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.