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Post by bones1026 on Apr 15, 2017 20:29:10 GMT -5
The guy who wrote the letter to the head of FDA, on xmas eve btw, advocating for the FDA to reject afrezza approval..currently being indicted and awaiting trial ..M. Hamburg was the head of FDA at the time and surprising did not approve Afrezaa which forced us to spend 100's of millions of dollars on new trials...she currently is also indicted and awaiting trial for her collusion on Levaquin...
So my point is...Why have we never heard anything about the obvious collusion(by more than just these two)going on to destroy a paradigm shifting drug, so these greedy bastards can make more millions?
I understand I am aware of this because of my investment in MNKD and not much I can do about it, but there has to be some investor, who has lost much more than my blue collar investment(even though its way more than I'd like to admit) that is able to simply connect the dots and see that something isn't right here..The drug is a total game changer. Good luck to all
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Post by derek2 on Apr 15, 2017 21:07:10 GMT -5
The guy who wrote the letter to the head of FDA, on xmas eve btw, advocating for the FDA to reject afrezza approval..currently being indicted and awaiting trial ..M. Hamburg was the head of FDA at the time and surprising did not approve Afrezaa which forced us to spend 100's of millions of dollars on new trials...she currently is also indicted and awaiting trial for her collusion on Levaquin... So my point is...Why have we never heard anything about the obvious collusion(by more than just these two)going on to destroy a paradigm shifting drug, so these greedy bastards can make more millions? I understand I am aware of this because of my investment in MNKD and not much I can do about it, but there has to be some investor, who has lost much more than my blue collar investment(even though its way more than I'd like to admit) that is able to simply connect the dots and see that something isn't right here..The drug is a total game changer. Good luck to all Easy - because the "obvious collusion" doesn't exist. 1. MNKD were not experienced with regulatory review and submitted an incomplete NDA with 2 versions of the Medtone inhaler that were not bridged, and that both had quality problems (breakage, blockage, mouthpieces coming off and posing a choking risk). CRL#1 2. They then re-submitted using in vitro bioequivalencey, ignoring an FDA request for a pre-submission meeting. CRL#2 3. They then got their act together and actually addressed the issues in their submission and performed the requested clinical studies. They also performed well at the safety meeting, and not surprisingly, they received approval (their performance at the safety meeting surprised me, actually). You can read my explanation of why Martin S. was a lucky bystander punk and not at all an influence on the FDA here. and here. Maybe you'll see the logic. If not, you're free to believe whatever you want - you're an adult, after all. |
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Post by sportsrancho on Apr 15, 2017 21:16:48 GMT -5
Bones....It takes that one person that is like a dog with a bone. That's keeps digging and won't give up. It happens:-)
My friend for 40 years was convicted of manslaughter and spent 10 years in jail. Year after year his lawyers appealed his case. The judge wouldn't listen. His been out for 5 years now and has started his life over. With a new wife and his 25 year old son by his side.
Last week he called me very excited. He had gotten exonerated, cleared of all charges. Someone from the University of Flagstaff took on his cold case. Worked years! Found out the FBI lied on the stand!
48 hours will be at my friends home next month. His name is Jason Krause and he lives in Prescott AZ.
He waited a long time for his truth to raise to the top. He is not bitter. And is happy to have his name cleared after all these years.
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Post by tiberious on Apr 15, 2017 21:35:51 GMT -5
What I am wondering is why would a government agency listen to Skrelli in the first place? Seems like a ruse to me. If you or I or Bill Gates for that matter send a mail to a bunch of FDA folks on the cusp of a PDUFA date what do you think your chances would be for any sort of attention to your email? Pretty much zero right. Now add to this the fact that Skrelli states in his letter that he is short the stock. Again, why at the last minute would they heed his warning on one of their own rules? Don't you think they knew about their rule regarding in vivo with the new inhaler leading up to the PDUFA? Makes you really think doesn't it? Skrelli... Hamburg... Hmmm. I wish someone would focus on just this aspect of the Mannkind saga and do a Erin Brockovich amount of investigation.
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Post by derek2 on Apr 15, 2017 21:43:47 GMT -5
What I am wondering is why would a government agency listen to Skrelli in the first place? Seems like a ruse to me. If you or I or Bill Gates for that matter send a mail to a bunch of FDA folks on the cusp of a PDUFA date what do you think your chances would be for any sort of attention to your email? Pretty much zero right. Now add to this the fact that Skrelli states in his letter that he is short the stock. Again, why at the last minute would they heed his warning on one of their own rules? Don't you think they knew about their rule regarding in vivo with the new inhaler leading up to the PDUFA? Makes you really think doesn't it? Skrelli... Hamburg... Hmmm. I wish someone would focus on just this aspect of the Mannkind saga and do a Erin Brockovich amount of investigation. Yep, they knew about their own rule all along and they enforced it. There was no last-minute change in decision. The infamous insider trading chemist proves it: 1. He started a long position in MNKD. 2. He checked in the FDA system and found that MNKD was destined for a CRL. 3. He sold his position before the CRL, avoiding a loss. Some will try to tell you that the trader stayed long because the FDA system said that MNKD were to be approved and he lost money. Not the case. It's the exact opposite. Either they don't understand reality or they're counting on you not to know it. Liang's MO was to start a position, check for approval sttaus and then either add or sell, depending on whether the drug was recommended for approval or not. www.sec.gov/litigation/complaints/2011/comp21907.pdf page 26 shows that he avoided a $60K loss by selling. |
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Post by sellhighdrinklow on Apr 15, 2017 21:53:39 GMT -5
The guy who wrote the letter to the head of FDA, on xmas eve btw, advocating for the FDA to reject afrezza approval..currently being indicted and awaiting trial ..M. Hamburg was the head of FDA at the time and surprising did not approve Afrezaa which forced us to spend 100's of millions of dollars on new trials...she currently is also indicted and awaiting trial for her collusion on Levaquin... So my point is...Why have we never heard anything about the obvious collusion(by more than just these two)going on to destroy a paradigm shifting drug, so these greedy bastards can make more millions? I understand I am aware of this because of my investment in MNKD and not much I can do about it, but there has to be some investor, who has lost much more than my blue collar investment(even though its way more than I'd like to admit) that is able to simply connect the dots and see that something isn't right here..The drug is a total game changer. Good luck to all Easy - because the "obvious collusion" doesn't exist. 1. MNKD were not experienced with regulatory review and submitted an incomplete NDA with 2 versions of the Medtone inhaler that were not bridged, and that both had quality problems (breakage, blockage, mouthpieces coming off and posing a choking risk). CRL#1 2. They then re-submitted using in vitro bioequivalencey, ignoring an FDA request for a pre-submission meeting. CRL#2 3. They then got their act together and actually addressed the issues in their submission and performed the requested clinical studies. They also performed well at the safety meeting, and not surprisingly, they received approval (their performance at the safety meeting surprised me, actually). You can read my explanation of why Martin S. was a lucky bystander punk and not at all an influence on the FDA here. and here. Maybe you'll see the logic. If not, you're free to believe whatever you want - you're an adult, after all. Why do you keep changing your profile pic? Easy to answer to most. |
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Post by tiberious on Apr 15, 2017 21:53:45 GMT -5
What I am wondering is why would a government agency listen to Skrelli in the first place? Seems like a ruse to me. If you or I or Bill Gates for that matter send a mail to a bunch of FDA folks on the cusp of a PDUFA date what do you think your chances would be for any sort of attention to your email? Pretty much zero right. Now add to this the fact that Skrelli states in his letter that he is short the stock. Again, why at the last minute would they heed his warning on one of their own rules? Don't you think they knew about their rule regarding in vivo with the new inhaler leading up to the PDUFA? Makes you really think doesn't it? Skrelli... Hamburg... Hmmm. I wish someone would focus on just this aspect of the Mannkind saga and do a Erin Brockovich amount of investigation. Yep, they knew about it and they enforced it. The infamous insider trading chemist proves it: 1. He started a long position in MNKD. 2. He checked in the FDA system and found that MNKD was destined for a CRL. 3. He sold his position before the CRL, avoiding a loss. Right... so they knew their own rules and had it in the system that they were going to approve and then flipped that decision in the system (after Skrelli's letter) and that's when the FDA chemist flipped his trade. What a mess! Again, sounds a little to convenient to me for those with short interests. Picture all the PHD's and bureaucrats and investigators in the FDA all of a sudden shocked to be reminded of a small codicil in their own rules regarding in vivo requirement. Ruse! |
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Post by derek2 on Apr 15, 2017 22:02:18 GMT -5
Yep, they knew about it and they enforced it. The infamous insider trading chemist proves it: 1. He started a long position in MNKD. 2. He checked in the FDA system and found that MNKD was destined for a CRL. 3. He sold his position before the CRL, avoiding a loss. Right... so they knew their own rules and had it in the system that they were going to approve and then flipped that decision in the system (after Skrelli's letter) and that's when the FDA chemist flipped his trade. What a mess! Again, sounds a little to convenient to me for those with short interests. Picture all the PHD's and bureaucrats and investigators in the FDA all of a sudden shocked to be reminded of a small codicil in their own rules regarding in vivo requirement. Ruse! There's no indication that the FDA ever were going to approve before CRL#2. That's a truism with no evidence. The only evidence is that Liang logged into the FDA system, on Jan4, the first day back from holidays, saw that the MNKD would be issued a CRL, and sold 2 weeks before the CRL. To think that government employees received Martin S.'s email after Christmas and in the intervening holiday week reversed decision on all of their scientists, changed all of their recommendations in the toxicology review, the chemistry review, the clinical review, the safety review, the cross-team-leadership review, the pharmacology review, in time for new years strains credulity. |
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Post by derek2 on Apr 15, 2017 22:06:59 GMT -5
Easy - because the "obvious collusion" doesn't exist. 1. MNKD were not experienced with regulatory review and submitted an incomplete NDA with 2 versions of the Medtone inhaler that were not bridged, and that both had quality problems (breakage, blockage, mouthpieces coming off and posing a choking risk). CRL#1 2. They then re-submitted using in vitro bioequivalencey, ignoring an FDA request for a pre-submission meeting. CRL#2 3. They then got their act together and actually addressed the issues in their submission and performed the requested clinical studies. They also performed well at the safety meeting, and not surprisingly, they received approval (their performance at the safety meeting surprised me, actually). You can read my explanation of why Martin S. was a lucky bystander punk and not at all an influence on the FDA here. and here. Maybe you'll see the logic. If not, you're free to believe whatever you want - you're an adult, after all. Easy to answer to most. Because I enjoy changing my picture. Others on here do so as well. I've changed it twice in the last 2 years, First my guitar then my face, now Big Al from the Country Bears Jamboree. If you miss them, here they are:   I must admit, the guitar is the prettiest of the 3 pics. |
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Post by mango on Apr 16, 2017 12:15:40 GMT -5
Derek2—your logic does not disprove the available evidence and FOIA requests.
And your logic completely ignores the fact that Renaissance Technologies had major transactions involving MNKD stock, in the excess of millions, during the time Margaret Hamburg was in charge of the FDA. Your logic also fails to acknowledge that Shkreli was not some "punk bystander" but a highly connected hedge fund owner and pharmaceutical company CEO. Your logic fails to acknowledge the fact that Shkreli did not only send a letter about MannKind, but also sent one to the FDA requesting to reject Navidea Biopharmaceuticals which he ALSO was shorting. Your logic fails to acknowledge the fact that Shkreli had completed a major naked short sale with his account with Merril Lynch through his hedge fund company MSMB Capital Management which is a major part of his federal charges. He relied on the devestation of both of these companies because he had millions in short positions and had to pay off all his debtors and debt and pay stockholders.
You also fail to acknowledge the fact that Shkreli founded his rare disease biotech company, Retrophin, in 2011 and would have never been able to do so had the FDA not given both MannKind and Navidea a hard time which resulted in major price drops, BOTH of which Shkreli had major short positions in. His future LITERALLY relied in their failures. Retrophin was also founded under MSMB.
I have researched this idiot for a couple of years along with the Hamburgs and I can toss out the chemist and still make it all a lot more logical than your logic.
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Post by derek2 on Apr 16, 2017 12:52:20 GMT -5
Derek2—your logic does not disprove the available evidence and FOIA requests. Then quote the evidence - show the results of the FOIA requests, not fairy tales and just-so stories that others have pointed to or made up out of whole cloth. Not fundraising letters from CREW, not blog posts from ambulance chasing, government hating lawyers. You claim there's evidence. Show it. I point directly to proven and sworn evidence by the SEC which resulted in the criminal conviction of Liang (jail time) and in a $3.4M civil penalty. Pretty good evidence. Once again: www.sec.gov/litigation/complaints/2011/comp21907.pdfIf, for example, you found 2011 FDA documents showing initial approval and then reversal, that would be a blockbuster! No evidence that this exists, of course. EDIT: For balance, here's the Shkreli letter that supposedly swayed the FDA from "approved" to "not approvable" in a 4-day working period (Dec 26 - Dec 31 2010) in time for Liang to sell his MNKD stock on Jan 4 2011 (first day back the next week). www.scribd.com/document/257574253/Afrezza-Review-for-FDAThe realistic view is that MNKD had been marked for a CRL before Boxing Day, when Shkrelli's email would have been received. His email changed nothing, and was just noise. The extraordinary claim is that the FDA and hedge funds were in bed and leadership went against their chemists, microbiologists, pharmaceutical experts, and statisticians to arbitrarily overrule them and change the recorded stance in the documents attested to by various FDA team leads and fabricate reasons for rejection to be included in CRL #2. |
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Post by brentie on Apr 16, 2017 14:07:30 GMT -5
Easy - because the "obvious collusion" doesn't exist. 1. MNKD were not experienced with regulatory review and submitted an incomplete NDA with 2 versions of the Medtone inhaler that were not bridged, and that both had quality problems (breakage, blockage, mouthpieces coming off and posing a choking risk). CRL#1 2. They then re-submitted using in vitro bioequivalencey, ignoring an FDA request for a pre-submission meeting. CRL#2 3. They then got their act together and actually addressed the issues in their submission and performed the requested clinical studies. They also performed well at the safety meeting, and not surprisingly, they received approval (their performance at the safety meeting surprised me, actually). You can read my explanation of why Martin S. was a lucky bystander punk and not at all an influence on the FDA here. and here. Maybe you'll see the logic. If not, you're free to believe whatever you want - you're an adult, after all. Why do you keep changing your profile pic? Easy to answer to most. Oh no , did I miss the memo where we can't change avatars anymore.  |
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Post by liane on Apr 16, 2017 14:10:42 GMT -5
How appropriate yours is brentie!!! You can change as often as you like. |
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Post by kc on Apr 16, 2017 14:42:29 GMT -5
Martin Shkreli single-handedly destroyed MannKind . I hope in his trials and tribulations that the court digs into all of it. I need all the issues he is charged with her not tied to MannKind but it would be nice if a prosecutor went after it. Doubtful. Hamburg is guilty as charged and they should tie together the Mistys of her husband's company. I hope this link works but sometimes it does not. It's a 60 page document that CREW filed with the SEC in 2012. Citizens for responsibility and ethics in Washington. crew.3cdn.net/f55aefe37e78fb8d0f_z2m6b08ki.pdf |
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Post by derek2 on Apr 16, 2017 15:19:18 GMT -5
Martin Shkreli single-handedly destroyed MannKind . I hope in his trials and tribulations that the court digs into all of it. I need all the issues he is charged with her not tied to MannKind but it would be nice if a prosecutor went after it. Doubtful. Hamburg is guilty as charged and they should tie together the Mistys of her husband's company. I hope this link works but sometimes it does not. It's a 60 page document that CREW filed with the SEC in 2012. Citizens for responsibility and ethics in Washington. crew.3cdn.net/f55aefe37e78fb8d0f_z2m6b08ki.pdf And yet the CREW letter does not mention MNKD. They attach Shkrelli's letter to the FDA re:Afrezza in one of the appendices, but I'm not sure why if they don't point to it in their letter requesting an investigation. They make no claims as to how the letter to the FDA broke any rules, changed any opinions, or affected the price of any securities. The letter seems to be mostly concerned with Neoprobe. Also, the letter has been hosted on this board for years. mnkd.proboards.com/post/53269/threadThe desire to identify a non-management bad guy is understandable, and Shkrelli's an a-hole, but the link between a poorly written screed sent over the winter holidays and the CRL just isn't there, and no proof has ever been produced. kc, I notice you linked to this thread on ST, claiming it's a review of how MNKD's financial troubles began. How so? I mean, first off, I debunk the truism that Martin S had anything to do with CRL #2, but let's put the cause of CRL 2 aside. We can both agree that CRL 2 caused delay and expense. But here's the thing: After approval, in 2014, MNKD peaked above $10 a share and they didn't raise funds. They then had two small run-ups in 2015 when once again they didn't raise funds. Seems their financial problems were behind them, at least in their opinion. Even _if_ Martin S. was the Dirk Dastardly that caused expense to MNKD in 2012, (and he wasn't,) by 2014 / 2015 that was ancient history. MNKD had a partner, $160M in up front money and the opportunity to tap into an equity raise. And they didn't. Did Martin S make them do that? In June 2014, MNKD was flush with cash. June 2014 - July 2015 offered MNKD a chance to raise as much cash as they needed and they didn't do it. They then failed to get to positive free cash flow over the next 2 years. _That's_ the cause of their financial problems. A lack of revenue while continuing to spend $10M a month for 2 years. |
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