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Post by spiro on Jan 29, 2014 11:29:38 GMT -5
Fraser, welcome to the board and of course that question was asked, but not really answered. We asked if they expect a partnership before approval. The response was some are interested pre-approval and some are interested post approval. it was also mentioned that Greenhill was doing a great job. We did not talk with any of the other participants at the conference. But of course, I would have liked to have told some of the major company representatives there, that there CEO is going to look pretty stupid in 2 years or so, if they passed on the opportunity to partner with MNKD. I hope this helps.
Spiro
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Post by spiro on Jan 29, 2014 8:50:10 GMT -5
I believe he said something like, it should be easy show clear superiority in post approval studies. hw did not elaborate on this issue.
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Post by spiro on Jan 28, 2014 20:14:48 GMT -5
I am the old guy on the right' t.
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Post by spiro on Jan 28, 2014 15:50:24 GMT -5
Johnathan Goldman showed us the cricket inhaler device. it looks to be about 1/2 the size of the dreamboat inhaler. Because of it's low cost, it will come loaded with the medication and then be discarded after one use. This is one neat looking device.
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Post by spiro on Jan 28, 2014 14:12:07 GMT -5
I just returned from the Drug Delivery Partnerships conference. Ashiwi and I had the opportunity to meet and speak with Al Mann, Andrea Leone-Bay and Johnathan Goldman both before the presentation and during the break. We thoroughly enjoyed both Al Mann and Andrea Leone-Bay's presentation. Al Mann's A game was on today and he presented an energetic and excellent keynote presentation. Andrea Leone-Bay is one sharp lady and it didn't take her long to get over my head on technosphere delivery. Doc Ashiwi seemed to keep up with her. All of them seemed very confident with Afrezza's progress thus far. Aside from Afrezza, Technosphere may have some extremely valuable indications. possibly equalling or surpassing Afrezza's potential. Ashiwi may be able to elaborate on this more. Ashiwi could be responsible for today's increase in share price. My confidence is at it's all time high now. I will continue to nibble and load the truck, when opportunities exist. You know, I could be wrong about MNKd, but it will not be because I failed to adequately research and study MNKD before jumping in. BTW, Al Mann ended his presentation talking about Technosphere and concluded by saying, " Imagine the possibilities.
Spiro
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Post by spiro on Jan 27, 2014 19:14:00 GMT -5
I am meeting Ashiwi at 6.45 tomorrow morning. We will register at 7:30 and then wait for Al's presentation at 8:30, followed by Andrea. We probably will not get near a computer until 12 noon. $5.23 has depressed us both a little. Hopefully something we hear tomorrow will cheer us up. I did pick up 20 more contracts toady for my already MNKD overweighted portfolio.
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Post by spiro on Jan 23, 2014 21:21:36 GMT -5
Babaoriley is giving very wise advice on this issue. !5% -20% of one 's net worth should indeed be a maximum risk in the stock market. But I also agree with taking a chance with MNKD being the only stock in that portfolio, Hopefully you are young enough to recover if you are wrong. Dang, why isn't MNKD over $10. by now?
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Post by spiro on Jan 22, 2014 19:05:37 GMT -5
Holy Toledo, what a comprehensive and well written article about Afrezza. How many shares does this guy own? I may have to rent a bigger truck.
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Post by spiro on Jan 20, 2014 10:15:34 GMT -5
So Baba, would a major partner only slightly relieve your concerns also? Some believe that the road ahead for Afrezza after approval is a nasty one. For me, I wouldn't have a penny of my money in this stock, if I believed that the road ahead after a major partner and FDA approval was anything less than a new 12 lane super expressway. Biotech investing is just too risky to feel otherwise. I know what it feels like to be on that superhighway, but I was only in a go cart that time. This time, I am driving an 18 ft Ryder rental. Some like Rak and Ashiwi are driving 18 wheelers. BTW, they were also on that same super expressway with me. Ashiwi was also in a go-cart, but Rak was driving a VW Beetle. In the unlikely event that I will be wrong about MNKD and Afrezza, my wife has already purchased a one-way ticket to Siberia for me. I wonder if they have the internet in Siberia?
Spiro
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Post by spiro on Jan 19, 2014 14:04:25 GMT -5
A1cc, My response to Chris wasn't a knee-jerk reaction. I read his nonsense last night. I actually think that there is a possibility that he holds a few shares. But, because of his low expectations, it's more likely that he either doesn't have a position yet or he is short a small amount of shares. If he seriously believes that a major partner would only slightly alleviate his questionable concerns, for me, it's hard to reach any other conclusion about him. If MNKD gets a major partner, the longs here will breathe a monstrous sigh of relief and enjoy a solid share price increase. JMHO
Spiro
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Post by spiro on Jan 19, 2014 11:51:23 GMT -5
Chris, i am a little surprised by the lack of supporting evidence for your low expect ions for Afrezza. It would indicate to me that you either hold a minimal long position or have a small short position. Personally, I don't invest in a stock, unless I have a firm belief, in it's eventually success. George Rho, Joe Springer and BeyondProxy have basically reached the same conclusion on Afrezza. They have quite extensive documentation and research to support their position and projections, for Afrezza's eventual success. It's also most likely that marketing studies conducted by MNKD, Greenhill and Deerfield also had similar results, indicating a favorable market acceptance for Afrezza. Anecdotal data from both doctors and diabetics is off the charts. Afrezza has super blockbuster written all over it. It's obvious that MNKD's share price direction will be influenced by numerous catalysts which could take it in either direction short term. A few of these catalysts could be, major partner or lack of, regional partner, outright buyout of Afrezza, Adcom committee approval or lack of and FDA approval or lack of. Secondary catalyst could include, foreign market approvals, substantial institutional buying, analyst upgrades, foreign country orders and Technosphere contracts. It's hard to believe that a long would write that a major partner would only slightly alleviate his concerns. HMMMM Also, can you name a few large drug companies with great products that didn't make it?
Spiro here, long and strong
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Post by spiro on Jan 18, 2014 8:48:16 GMT -5
Chris, what is it about George Rho's comments you don't like? He seems to basically mirror BeyondProxy and Joe Springer in his optimism regarding the potential for MNKD and Afrezza. I actually think all three of them are a bit conservative in their estimates. I think that most analysts are ignoring the enormous potential that Technosphere may have in being used with other drugs. Also, quite a few potentially huge drug candidatesl have been rejected by the FDA, because of liver toxicity issues. By it's ability to bypass the liver issues, Technosphere could revive many of these drugs, particularly in some promising cancer drugs that have been halted, because of liver toxicity. I am looking forward to the Drug Delivery Partnerships Conference on January 28, where I believe this issue will be addressed by Al Mann and/or Andrea Leone-Bay. Stay tuned
Spiro
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Post by spiro on Jan 17, 2014 15:15:46 GMT -5
Jerk and moron are way too nice for that low life.
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Post by spiro on Jan 17, 2014 14:20:09 GMT -5
Another nonsense hit piece from Seeking Alpha.
Nope, there is only one candidate on the horizon that meets our needs, and that bad boy is MannKind Corp. (MNKD). After listening to CEO Alfred Mann's presentation at the J.P. Morgan Healthcare conference yesterday, I lost all confidence in the company's lead clinical candidate, Afrezza. I now believe the product is destined for a rejection from the FDA, and it will essentially be the death knell of the company.
Prior to this presentation, I thought Afrezza was a relatively benign product that would squeak through its upcoming PDUFA date, and the company would be put up for auction soon thereafter. But what I heard made me take a second look, and the more I dug into this story, the more it fell apart at the seams.
So here is the basic bull thesis: Afrezza is an ultra-fast acting insulin that better mimics the physiology of the pancreas than currently available products. So it's supposed to be superior to fast-acting insulins like Novo Nordisk's (NVS) NovoLog. Secondly, patients will prefer to use Afrezza because it's inhalable, and people generally don't like injections. Flowing from these 'axioms', one would naturally conclude that Afrezza will eventually come to dominate the insulin market, a multi-billion dollar space.
Backing up my brief summary of the bull thesis, here are some paraphrased tidbits of what the CEO said yesterday:
· First product that matches the physiology of the pancreas
· Substantially lower risk of hyperglycemia
· Weight neutral, better than current products
· No safety signals
· Believes Afrezza will grow market among Type II because of lower risk of hyperglycemia
· Product is easy to use, delivers insulin in less than a second
· Clinically superior product compared to NovoLog
The problem with some of these statements is that the Phase 3 clinical trial data actually refutes them. And the funny part is that Mr. Mann made some rather odd statements explaining the mismatch between the company's position on Afrezza's performance compared to the actual trial results.
Turning to the trial results, Afrezza did not outperform NovoLog in terms of A1c levels in type 1 diabetics. It actually performed worse. So Mr. Mann touting Afrezza's 'clinical superiority' is a factually incorrect statement. But what is extremely bizarre is his explanation. During his presentation, he actually blames the patients in the clinical trial for improper fasting procedures, saying that once patients learn how to use the device properly that Afrezza's superiority will be apparent.
I can't say that I've ever heard a CEO blame patients in a clinical trial for their product's performance, but sure, why not?
But it gets better. In the introduction, Mr. Mann claims that Afrezza/Dreamboat are so easy to use that a 4 year old can use it. So let me get this straight, it's so easy a 4 year old can use it, but the patients in the clinical trial were using it improperly?
Which is it?
Mr. Mann also claims that Afrezza offers a "weight advantage" in that it's weight neutral. In Affinity 2, however, patients gained an average of 3.5 lbs when using Afrezza. That's not weight neutral.
Finally, Mr. Mann preaches about how it's "impossible" for Afrezza to cause hypoglycemic events when used properly. According to the clinical trials, however, Afrezza caused more hypoglycemic events than placebo in type 2 diabetics.
So what is the truth? Is everyone using the device improperly? Does that mean it's not so easy to use?
While this may look like I am parsing the man's words, these discrepancies speak to a larger problem with these clinical trial results. The company has been repeatedly criticized for not being more transparent with the results with investors, especially heading into a regulator meeting with the FDA.
Basically, MannKind is telling investors to take their word for it. But as I've shown, their words do not necessarily match reality. The FDA isn't going to be so kind, trust me on that. If Mr. Mann goes beyond the realm of the data, he will more than likely be questioned on it.
So, let's ask a simple question: Why should the FDA approve this product?
Firstly, it offers no clinical advantage per the clinical trial results compared to existing therapies, despite what the company says. In the best light, you could say that it does as well as existing therapies. But you can't tell the FDA the product is clinically superior without actual data to prove it. That dog won't hunt.
Secondly, there is no patient advocacy surrounding the product. While many MannKind investors believe diabetics are scared of needles, the truth is that they generally are not. Try reading any of the numerous blogs on this issue, and you'll see that many diabetics are annoyed by MannKind investors suggesting that diabetics suffer from needle-phobia. I suspect this is why the big pharmas ditched their development programs altogether, as patients don't seem to despise needles as much as the industry thought they did.
At the end of the day, MannKind is left with one card to play: the product is inhalable. Is that enough to get past the FDA? Maybe, maybe not. But they are going to get hammered if they start spouting off about clinical superiority.
Unknowns and the possibility of Black Swans
Getting to the real reason I feel MannKind is going to implode is that there appears to be a very good chance of a Black Swan making an appearance in the briefing documents. The mismatch between the results provided to the public so far, and Mr. Mann's belief in the product's performance, are clearly at odds with one another. My bet is that these are the best results the company has to offer, and there are some naughty surprises that will be revealed in the briefing documents. And this, my friends, is why I suspect the FDA called an Advisory Committee in the first place. If these trial data looked as impressive as the company claims, an Advisory Committee would be a waste of time and effort. So, I don't think they called an ADCOM to rubber stamp Afrezza.
Think about it this way. If reality coincided with Mr. Mann's view of Afrezza, why hasn't a big partner stepped in to either buy the company or partner? The answer is obvious: they don't share his outlook. They either believe Afrezza will be rejected again, or its sales will underwhelm.
My view is that Mr. Mann has gotten emotionally involved in the development of this product, and has therefore lost sight of its significant shortcomings. That's a recipe for disaster.
So in conclusion, my bet is that Afrezza will indeed be rejected come April, and MannKind shares sink below $1. If you're long this stock, you should think carefully about hedging this position.
Additional disclosure: I am using Deep OTM Puts to go short MNKD.
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Post by spiro on Jan 16, 2014 9:09:41 GMT -5
Rak, thanks for bring my errant post back to the top. Geez, I used to think, I didn't have any enemies on this board. LOL
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