OK I finally have a few minutes to relate to you all about this morning. WOW, as Spiro already expressed we both left never feeling more confident about MNKD. Remember this was a meeting about Drug Delivery. With lots of big and small pharma companies in attendance. Al Mann delivered a great keynote address giving us a run down of his amazing career. From US gov't aerospace to the Pacemaker, Minmed, insulin pump, Cochlear implant, Retina implant. He has sold 11 companies for something around 8 billion dollars. He was extremely cordial and friendly and we had a few nice conversations. His goal in life is to meet unmet needs. It's what keeps him going. As he was saying that I saw his wife (who was sitting directly in front of me) nodding her head in agreement. It certainly doesn't look like he's about to slow down anytime too soon. Some stats he mentioned that in 10 years 1/2 half of all adults will be either diabetic or pre-diabetic and the cost to healthcare will be 3.5 Trillion dollars. He went on with some of the benefits of Afrezza which most of you reading this already know. He did mention that a post-approval study will be done to show that Afrezza will show superior A1c. The current studies showed that it is non-inferior. He is very confident it it's reduction of A1c. All endpoints were met and they are optimistic regarding approval, but you just never know with the FDA.
He is involved with another company that is working on a basal insulin patch. This would compliment the prandial insulin supplied by Afrezza. Still years away. Enormous potential in my opinion. He believes that the deficiencies in the current insulins have brought many oral meds such as Metformin to market. Many of these have side effects and are detrimental in the long run. Afrezza early on could reduce these pills as well.
Technosphere has as much if not more potential in the market place as Afrezza. It was very technical, but Dr Leone-Bay gave an excellent presentation on the actual process. Could be a bout 20 different indications for Technosphere with Pain being # 1. This is where the Cricket device will be utilized. It's a one time device which is tiny and very easy to use. Have a migraine? Take a hit on your Cricket. Bam you are feeling relief. Technosphere for pain will compete with Opioids such as Morphine but with no side effects. There are studies taking place now with mice. Another indication was found to decrease food consumption. How big is the weight loss market???$$$. Technosphere will NOT be utilized with Viagra as it would lower blood pressure too fast.
Any way just to repeat Al Mann's closing statement as Spiro already stated "... Imagine the Possibilities...
Sentiment: Strong Buy
I'm confused about one point from this summary. Can someone who has a guest login on ProBoards or who knows Ashiwi or Spiro confirm the statement by Al. . . "He did mention that a post-approval study will be done to show that Afrezza will show superior A1c. The current studies showed that it is non-inferior. . . ."
We know 171 was non-inferior. But Study 175 was set up for superiority. Superiority was the endpoint. As we know, Al stated a month prior to data release that "more than a .5" was needed in 175 for superiority. We know only a .4 was achieved, but MNKD has maintained that the .4 did in fact unequivocally establish superiority (at the p = .0001 level). But today Al apparently said (at least according to Ashiwi in the summary above) that all "current studies showed non-inferiority." What did Al mean by this? Even the JP Morgan slide #24 says 175 achieved the primary endpoint of superior A1c lowering. Perhaps Al misspoke?
Or is Al back tracking now and saying the .4 in 175 only achieved non-inferiority? If so, it did not meet the endpoint. The endpoint in 175 was superiority, not non-inferiority. Someone please ask Ashiwi what he meant by that and let us know. If the endpoint was not achieved 175, there will be no label expansion.
I need clarification. Perhaps something was lost in translation. Ashiwi did say that Al said all endpoints were met so I'm confused. Someone please help. Thanks in advance.
Rapp, you may be confusing T1 and T2. T1 is non-inferior. T2 is superiority. Al is referring to T1 in his speech yesterday. Below is the exact words from Al during the November 2013 investor conference:
"As in earlier trials involving patients with Type 1 diabetes in Affinity 1, that is MKC 171, AFREZZA showed a substantially reduced incidence of severe hypoglycemia, last weight gain and much better prandial excursions while also achieving the primary endpoint of non-inferiority and lowered HbA1c as compared to the rapid acting analog which provides today's best prandial insulin therapy....
...In the AFFINITY 2, our MKC-175, we observed that the addition of AFREZZA to a regimen of oral medication produced an average drop in HbA1c of more than eight-tenths of 1% demonstrating superiority compared to the oral-only group and with a P value that is the statistically equivalent of a home run. These results indicated AFREZZA is an effective first insulin for patients with Type 2 diabetes who are insufficiently controlled with oral anti-diabetic agents
By the way, I read all your posts because it is a good bell weather of 'what can go wrong' since you seem to specialize in looking for holes. But so far, it gives me confidence that you haven't really found anything of serious concern.
If you do not understand the difference between statistical and clinical superiority, then I suggest you go back and do significantly more due diligence. Statistical superiority can be established with as little as a 0.0000001% or less difference.
The 0.5% reduction was an off the cuff unofficial goal stated in response to a question, and not an required end point. The required end point was "statistical superiority," which was conclusively shown. In addition, "clinical superiority" was also conclusively shown by the much larger percent of patients whose AC dropped below targets 6.5% and 7% versus the placebo arm. The independent regulatory consultant, who reviewed the trial results for Deerfield, clearly understood this.
In addition, if as you claim Afrezza did not meet its required end point in the 175 trial and therefore there can be no label expansion, then please explain how Lantus has a label expansion when their own trial result with Lantus/oral med was less then that of Afrezza/oral med?
If all you want to do is twist data, and not deal with the FDA's own definition and descriptions of these different terms (e.g. statistical superiority, clinical superiority), then you do a dis-service to everyone on this board. However, regardless, thank you for bumping Elmastro's post.
It's funny that you spend so much time trying to disprove everything that comes from this company and their trial results on here. For all the time you spend here typing, you could have easily just called or emailed Matt and asked him. So why is it that you so scared to call the company and ask for clarification in regards to the endless dribble you continually vomit on here? Only someone with an agenda would do what you do when you could so easily just ask Matt. I'll even help you by posting the info. Report back when Matt has set you straight.
But we won't hold our breath because we know full well you have no intention of calling Matt for answers. Your agenda isn't about getting answers, it's about instilling confusion and fear. And for that, I hope Karma hits you harder than the polar vortex, you POS.
Primary IR Contact
28903 North Avenue Paine
Valencia, CA 91355
Phone: (661) 775-5300
Spiro went to the conference with ashiwi from the ProBoards site. Are you saying that you are ashiwi? If not, did you speak with Al Mann and Dr. Bay as well? If so, can you share any of their comments? Thanks.
Sentiment: Strong Buy
thanks elmaestro... very detailed and easy to understand... well maybe for everyone except getaclue... I think he is still confused with the first word.... I hear he thinks you started your post with Oklahoma!!!!! no wonder he is clueless.