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Post by rak5555 on Mar 29, 2014 10:12:45 GMT -5
I prepared the following for a friend that was whining about the BD, then decided to post here.
I can't believe that you of all people have lost the faith. And why, just because some fda flunkies did their usual hatchet job preparing docs for an adcom? the type 2 data is strong enough for approval and type 2 represents 95% of the market. while they pointed out weaknesses in type 1 data, it still met endpoints or DF would not have forked over the $. Its like they took a pass/fail course and now the professor wants to withhold credit because they barely passed. Plus, as you reminded me yesterday, type 1 was going to be approved by fda on prior submission. the briefing docs concede that the bridge between medtone and dreamboat has been established, thus prior trial data is in play. so, let me see if I got this right, the fda was going to approve type 1, but denied approval pending in vivo trials they helped to design and then when those trials met the fda's agreed upon endpoints, they now want to nit pick other extraneous data elements as a basis for rejection. I suppose if you did enough trials you could always find some negative to exaggerate, and that is what they have done.
don't get me wrong, I am highly concerned with the overall tone of the BD and as a result, I reduced my overall exposure. But I have not given up. MNKD could thrive on just a type 2 approval while they work w/ a partner to gain approval for type 1 and expand the label.
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Post by ashiwi on Mar 29, 2014 10:26:49 GMT -5
Thanks Rak for your level headed voice of reason. It was certainly a depressing Friday after we thought the pain was over in the morning. I am still fully loaded with my shares, but I also have not slept very well the past few days. Taking some $ off the table by selling puts and calls have helped, but I have not sold a share in years, only added. I don't foresee sleeping any better the next 2 weeks, but I see light at the end of the tunnel which has been greater than 4 years for me. I just don't see a reason why Afrezza won't be approved. It's just a shame that there appears to be so much hatred towards MNKD. All Al Mann wants to do is help people and make a better quality of life for diabetics.
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Post by spiro on Mar 29, 2014 11:00:08 GMT -5
Damn Rak, now everybody knows that I am a whiner. Actually I have not lost faith in Afrezza and Technosphere. But I must admit the BD has eliminated most of my irrational exuberance. It's obvious now, that Ashiwi is the most optimistic poster. I still believe that the only thing that can prevent FDA approval of Afrezza is FDA politics. That is what bothers me the most in the BD. Other posters have pointed out the editorializing of the FDA concerns. I am no longer madly in love with MNKD. Let's say, I am now down to having a big crush on MNKD. Babaoriley's wisdom has influenced my emerging caution.
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Post by jpg on Mar 29, 2014 11:19:24 GMT -5
I prepared the following for a friend that was whining about the BD, then decided to post here.
I can't believe that you of all people have lost the faith. And why, just because some fda flunkies did their usual hatchet job preparing docs for an adcom? the type 2 data is strong enough for approval and type 2 represents 95% of the market. while they pointed out weaknesses in type 1 data, it still met endpoints or DF would not have forked over the $. Its like they took a pass/fail course and now the professor wants to withhold credit because they barely passed. Plus, as you reminded me yesterday, type 1 was going to be approved by fda on prior submission. the briefing docs concede that the bridge between medtone and dreamboat has been established, thus prior trial data is in play. so, let me see if I got this right, the fda was going to approve type 1, but denied approval pending in vivo trials they helped to design and then when those trials met the fda's agreed upon endpoints, they now want to nit pick other extraneous data elements as a basis for rejection. I suppose if you did enough trials you could always find some negative to exaggerate, and that is what they have done.
don't get me wrong, I am highly concerned with the overall tone of the BD and as a result, I reduced my overall exposure. But I have not given up. MNKD could thrive on just a type 2 approval while they work w/ a partner to gain approval for type 1 and expand the label. Do you know if the tone to this BD is typical or/ similar to other BDs? I must admit to rarely reading them (I don't usually invest in these binary events) as well as I did with Afrezza...
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Post by bigboy on Mar 29, 2014 12:13:41 GMT -5
All, First post, long time MNKD holder (near IPO). I'll be at the AdCom on Tuesday. Should be fun. Couple of thoughts:
No one knows what the FDA will do. Everyone has their own agenda. Lots of fear in the air on Friday, and good investment decisions are rarely made in such a setting.
I expect a good discussion on Tuesday. I do not believe in a conspiracy against MNKD. Novel, new therapies are to be well scrutinized. With a stellar safety profile and a very deliberate relationship with the FDA we will be approved on both sides.
Ignore the smoke. It shall remain thick.
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Post by nadathing on Mar 29, 2014 13:31:26 GMT -5
Re: "Do you know if the tone to this BD is typical or/ similar to other BDs?"
Thank you. I think many people don't realize that. The FDA is charged with protecting the general public and scrutinizing new drugs with a fine tooth comb is essential for the safety of potential users. If the FDA did not raise these issues and conduct a thorough hearing they would be accused of collaborating with MNKD (or any pharma) and negligence should an issue arise post approval. Friday was depressing and unnerving, but as many had posted in the days leading up to the BD the shorts would nit pick and launch an all out attack. They drove the pps down, but not nearly as much as they had hoped for.
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Post by thekindaguyiyam on Mar 29, 2014 13:54:24 GMT -5
There are two systems. One is short. The other long. Each has there own methods to motivate belief. The longs use science. The shorts result to emotion/fear. Each has a series of publications with writers willing to say anything to authenticate their position. When knowingly lied too; I tend to get contrarian confirmation that my belief system is rational and justified. This isn't the "news" that is neutral and believable. Each piece is designed to fortify or scare. imho
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Post by babaoriley on Mar 29, 2014 15:35:33 GMT -5
What an excellent thread you started, rak! I appreciate and respect your "Victor Lazlo" fire 'em up words!
A few observations:
1. How in the heck was the stock up so strong in the morning?
2. "missing data" and other key language in the BD actually make me think that the reviewing people were in someone's pocket (I don't buy into conspiracy theories, but if you can't get to AdCo and/or FDA members, and you're short massive amounts, that's a nice little ace in the hole to have, just so you can cover at a reasonable price. The shorts appeared to act as though they had a ace in the hole the past couple of weeks, didn't they. I expect AF to have quite the field day with the uses of those words by Monday morning, I don't believe we seen the last of him pre-AdCom.
3. Spiro, my friend, if you haven't lost faith in MNKD, then I question why you told me you were sticking pins in an Al Mann doll all yesterday afternoon. At least you haven't lost your AF doll! Based on how I was feeling at various time yesterday afternoon, it's clear that Spiro has not lost his Baba doll, either.
4. Because I don't understand the science nearly as well as most of you guys, I still am somewhat dumbfounded as to how we seemed to lose ground on the Type 1 trial, and, even though it came with a Shrkeli of being approved last go round, now it seems to trail Type 2.
5. No drug is perfect, all have pluses and minuses, but we have some important pluses with Afrezza. I'm sure we would all have loved to hear that in all their years, the briefing doc writers have never seen such a wonderful drug up for approval, with absolutely no downside and nothing but upside (in other words, similar to how this board and several others generally read), but their job is to point out weaknesses, let the AdCom discuss them, if they feel discussion is warranted, and let the FDA make the final decision. As Newbie so aptly pointed out, that's their job (oh, and to scare the crap out of us).
6. I have been planning to sell a decent portion of my holdings before AdCom all along, but it was supposed to be a happy, easy sale, with prices rising, or at least firm. I came close to not selling any cuz I was upset, but did end up doing the prudent thing, getting rid of a slug of warrants at an average price of $2.18.
7. Ashiwi, my brother in options, I was fortunate, having $5, $4.50, $4 and even some $3.50 puts, all expiring yesterday; I closed out the $5's and even the $4.50's for cheap early in the trading day, as I could not justify holding to close for .05, and glad I didn't, at least with the $5's. Our repeated sales over the years will take a little out of the sting of a poor outcome, but the big sting for me will be if we miss out on the expected windfall.
8. I trust the folks on the AdCom are wise to what the big picture, after all, this is certainly not their first rodeo; they will be looking at a drug and a delivery that can really help lots of people, without hurting many. I trust our presenters will make the case for Afrezza convincingly, and are able to refute or at least diffuse the controversial, editorial-like, remarks in the briefing docs. For those of you there in person, or listening live, please let us know if you feel our guys are being effective.
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Post by alcc on Mar 29, 2014 15:57:45 GMT -5
1) Re "missing data" and other key language", definitely points to a big negative agency bias imo.
2) Re "with[in] a Shrekli of being approved last go around", looking back I would say that was pure spin/speculation.
3) Also, do you see any confirmation of Al's claim that "half the hypos came from one subject"? I don't.
4) I am less worried about the adcom than I am the FDA. I would assume the writers/reviewers of the BD will be presenting to the agency's internal review meetings. Ugh.
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Post by mannmade on Mar 29, 2014 18:48:00 GMT -5
I have been thinking a lot as have you all about last Friday and the information that flew by from all corners yesterday... and that we have been trying to make sense of ever since... Like you Baboriley and most others... I felt that "Freedom Wednesday" was a good bet as prior to 10:30am/pst the stock had hit 5.95 and I felt like after Ad Com on Tuesday it would go higher on Wednesday and I could begin to see my financial freedom on a short horizon along the same time frame as the roll out of Afrezza...
Like many of you I am heavily invested for the last 4 1/2 years. Bought my first shares at 3.81 and bought significant (six figures) number of shares at 1.82 after the bottom of 1.57 a while back and have been accumulating ever since. Did not buy because I am so smart as an investor, I bought because like most everyone else I believe in what I was told and the consensus of understanding and agreement I found in numerous postings over the last few years along with extensive due diligence with doctors, news articles, and meetings with Mannkind. I also consulted some tea leaves (e.g.: Deerfield conversion, Bill Doub article, Exhubera was passed, etc...) So I have made my bed and am going to lie in it with no plans to sell on Monday as I still expect a positive result on the vote concurrent with what Jeff Eisenman articulated in his recent article.
One thing I would like to note is that we have been told that Al Mann and company see this as a "new first in class drug," so as for being less effective I think this is nonsense as they are comparing apples to oranges. Afrezza if (when approved) will create a new treatment protocol which ultimately may become the standard of care. But with that you have to develop new ways to assess success and effectiveness.
Much of my knowledge and motivation for investing (yes I would like a nice return for my efforts and holding long) so heavily in Mannkind comes from my brother who is now 56 has been a T1 since he was 8. We found him unconscious in his own vomit many times over the years and had to rush him to the hospital. Not only is he now obese he has had his eyes cauterized several times to prevent bleeding, he has many scars from not healing properly, and is now on dialysis while awaiting a kidney and pancreas transplant. And lastly he is still upset that as a child our parents would not let him go camping/hiking for a week in the grand canyon etc, as his two other brothers did, for their fear of his not being able to control his blood sugar (similar to what Afrezzauser spoke about when windsurfing in the Ocean in several of his posts) And all of this while my brother was one of the first to embrace the mini med pump and multiple basal injections a day instead of one in the morning. As background he has a degree in biology and probably knows as much about this disease as anyone I know...
So I have seen first hand what this disease can do over one's lifetime. I cannot in good conscious believe given everything we know about Afrezza that the FDA will not accept/approve Afrezza as an optional prandial treatment or additional treatment in helping to control diabetes, not if they truly understand this disease. I mean what's to lose when you ask my brother...
Having said all of the above, I had to do some soul search this past 24hours, along with no sleep while reviewing all the articles and docs and relevant message postings I could find. I want to thank everyone who has contributed to this board as I have read every post since the agoracom days... and I know most of you will, like me and a friend of mine, be up and glued to the webcast at 5:00am/pst. I have taken the day off of work because I still believe in Freedom Wednesday... And I just don't think there is anymore we can do... except have faith as we understand the facts available to us...
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Post by liane on Mar 29, 2014 19:08:27 GMT -5
Very well said mannmade; and thank you for sharing your brother's life with us. I hope that for him and all the other diabetics, this comes to pass. As you said, there is nothing more to do at this point - it's like waiting for Santa to come.
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Post by mannmade on Mar 29, 2014 19:23:01 GMT -5
Thanks guys... Really think we should plan a group party in Hawaii when all is said and done... So long as we can afford it... Ha Ha... Btw, Spiro I have a 60 year old (was 50 when I received it) bottle of Scotch I am waiting to open on the 15th. Hopefully that is... I will have said reason. And Liane too bad we can't wake up early and sneak a peek and then rewrap... GLTA!
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Post by alcc on Mar 29, 2014 19:24:30 GMT -5
Ditto. If this comes to pass, it will be a nice payday for us but a potentially new paradigm and better life for diabetes sufferers. If it does not come to pass, it will be a small setback for me, but a sad, sad day for many millions of patients.
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