marsie
Lab Rat
computer programmer
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Post by marsie on Jan 11, 2016 19:39:32 GMT -5
It is Martin Shkreli.
1. A few years back while FDA had meant to approve Afrezza, they got a letter from Shkreli. How would people know FDA was originally meant for approving Afrezza when a short period later the decision is a NO?
An FDA personnel later was in trouble bought over 10 stocks including all approved drug companies, including MNKD. Only the night before the final decision came out. He sold it.
I think if you want to dig this FDA person, you can find him in published articles.
You all know how things go. More trials, more studies, more money.
FDA people come and go. Afrezza labels are complicated.
Whether Afrezza labels would be complicated like this a few years back when FDA meant to approve it the first time around? That is my question.
Sometimes, when a small thing takes effect, even though it seems small, the ripple effect is the determine factor which bring something down or help something make it.
2. About Martin Shkreli.
He was shorting MNKD while he was writing letter to FDA.
Martin Shkreli was clearly not successful at hedge fund. The media put a smart kid picture on him, but actually he was kicked out of an elite high school. Frankly, I see lots of kids slack off in elite high school, few got kicked out. My point is, he is not bright, he is just dirtier than the average person. And, that seems to be what it takes to make it as far as to Shkreli.
Judging the out come of employee/researcher/executives of MNKD and Martin Shkreli just by the fact that one work for 10 years trying to work out a product which at least can improve the quality of life of some old folks. (Needles isn't going to be fun for old folks daily.) and someone who gained tremendous wealth by shorting stock and writing letters to FDA etc. Even though MNKD executives might have made mistakes, but mistakes are meant to be made and corrected.
I think MNKD can still over come all these, it is just a matter of time and cash.
They should have partnered someone who can commit longer, not so easily willing to give up.
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Deleted
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Post by Deleted on Jan 11, 2016 19:49:09 GMT -5
I would say who ever designed the trials
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Post by kbrion77 on Jan 11, 2016 19:54:00 GMT -5
I would say who ever designed the trials Novo, Lilly, Sanofi, etc. |
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marsie
Lab Rat
computer programmer
Posts: 26
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Post by marsie on Jan 11, 2016 19:59:13 GMT -5
Afrezza is clearly working. You can always pick the bone of the egg if you are the person who says Okay or Not Okay.
A human's lung spread out is as big as a football field. Humans breathe in dirt, other particles into lungs. Humans lived through gathering and hunting around fire, cooking around fire.
Have you blown ashes from stove before?
Technosphere pieces are so much smaller than any of these.
Do smokers need to do smoke test before buying cigarette.
Nevertheless, I think the label thing can be overcome. It is just MNKD is short of cash.
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Post by mindovermatter on Jan 11, 2016 20:17:39 GMT -5
Afrezza is clearly working. You can always pick the bone of the egg if you are the person who says Okay or Not Okay. A human's lung spread out is as big as a football field. Humans breathe in dirt, other particles into lungs. Humans lived through gathering and hunting around fire, cooking around fire. Have you blown ashes from stove before? Technosphere pieces are so much smaller than any of these. Do smokers need to do smoke test before buying cigarette. Nevertheless, I think the label thing can be overcome. It is just MNKD is short of cash. Tennis court. Not football field. And talking about football, Mannkind is not unlike the MN vikings field goal kicker. |
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Post by derek2 on Jan 11, 2016 20:29:41 GMT -5
It is Martin Shkreli. 1. A few years back while FDA had meant to approve Afrezza, they got a letter from Shkreli. How would people know FDA was originally meant for approving Afrezza when a short period later the decision is a NO? An FDA personnel later was in trouble bought over 10 stocks including all approved drug companies, including MNKD. Only the night before the final decision came out. He sold it. You all know how things go. More trials, more studies, more money. FDA people come and go. Afrezza labels are complicated. Whether Afrezza labels would be complicated like this a few years back when FDA meant to approve it the first time around? That is my question. Sometimes, when a small thing takes effect, even though it seems small, the ripple effect is the determine factor which bring something down or help something make it. 2. About Martin Shkreli. He was shorting MNKD while he was writing letter to FDA. Martin Shkreli was clearly not successful at hedge fund. The media put a smart kid picture on him, but actually he was kicked out of an elite high school. Frankly, I see lots of kids slack off in elite high school, few got kicked out. My point is, he is not bright, he is just dirtier than the average person. And, that seems to be what it takes to make it as far as to Shkreli. Judging the out come of employee/researcher/executives of MNKD and Martin Shkreli just by the fact that one work for 10 years trying to work out a product which at least can improve the quality of life of some old folks. (Needles isn't going to be fun for old folks daily.) and someone who gained tremendous wealth by shorting stock and writing letters to FDA etc. Even though MNKD executives might have made mistakes, but mistakes are meant to be made and corrected. I think MNKD can still over come all these, it is just a matter of time and cash. They should have partnered someone who can commit longer, not so easily willing to give up. Martin wrote his letter on Christmas day, and we know that the FDA had Afrezza marked for a CRL on the second day back in the new year. Maybe earlier. At least a full 2 weeks before they informed MNKD. There was simply not enough time for his letter to have an effect. between Christmas and New Year. 10 months of analysis by FDA scientists and an email causes a reversal? It strains credulity. Think about it. "Oh no, some self-admitted short seller sent us a screed. Put it in the pile along with the vaccine deniers, Deepak Chopra fans and homeopathists." Actually, more likely: "....", which is to say it probably wasn't even considered. Shkreli was just in the right place at the right time and was promoted to head villain by investors stung by the FDA, despite thin evidence. |
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Post by jpg on Jan 11, 2016 20:42:45 GMT -5
Martin wrote his letter on Christmas day, and we know that the FDA had Afrezza marked for a CRL on the second day back in the new year. Maybe earlier. At least a full 2 weeks before they informed MNKD. There was simply not enough time for his letter to have an effect. between Christmas and New Year. 10 months of analysis by FDA scientists and an email causes a reversal? It strains credulity. Think about it. "Oh no, some self-admitted short seller sent us a screed. Put it in the pile along with the vaccine deniers, Deepak Chopra fans and homeopathists." Actually, more likely: "....", which is to say it probably wasn't even considered. Shkreli was just in the right place at the right time and was promoted to head villain by investors stung by the FDA, despite thin evidence. Do not forget Martin had a very valid point about human testing. He did rightfully point out the FDA would have broken their own rules had they approved a device never tested on humans. This was a potentially very big issue if things hadn 't gone well down the road. |
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marsie
Lab Rat
computer programmer
Posts: 26
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Post by marsie on Jan 11, 2016 21:00:15 GMT -5
How can FDA approve anything without testing on HUMAN.
Of course, it was tested on HUMAN, it is equivalence/biosimilar (something like that) trials.
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Post by rockstarrick on Jan 11, 2016 21:04:35 GMT -5
Afrezza is clearly working. You can always pick the bone of the egg if you are the person who says Okay or Not Okay. A human's lung spread out is as big as a football field. Humans breathe in dirt, other particles into lungs. Humans lived through gathering and hunting around fire, cooking around fire. Have you blown ashes from stove before? Technosphere pieces are so much smaller than any of these. Do smokers need to do smoke test before buying cigarette. Nevertheless, I think the label thing can be overcome. It is just MNKD is short of cash. Tennis court. Not football field. And talking about football, Mannkind is not unlike the MN vikings field goal kicker. Go Hawks !! |
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Deleted
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Post by Deleted on Jan 11, 2016 21:11:00 GMT -5
Afrezza is clearly working. You can always pick the bone of the egg if you are the person who says Okay or Not Okay. A human's lung spread out is as big as a football field. Humans breathe in dirt, other particles into lungs. Humans lived through gathering and hunting around fire, cooking around fire. Have you blown ashes from stove before? Technosphere pieces are so much smaller than any of these. Do smokers need to do smoke test before buying cigarette. Nevertheless, I think the label thing can be overcome. It is just MNKD is short of cash. If the label was better, There would be no choice for doctors and insurance companies to get on board and revenues would have exceeded expectations |
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Post by jpg on Jan 11, 2016 21:12:02 GMT -5
How can FDA approve anything without testing on HUMAN. Of course, it was tested on HUMAN, it is equivalence/biosimilar (something like that) trials. The Dreamboat was not tested on humans... This was and still is against their own rules which Mnkd tried sidestepping with rheir modelization. |
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Post by esstan2001 on Jan 12, 2016 8:56:32 GMT -5
How can FDA approve anything without testing on HUMAN. Of course, it was tested on HUMAN, it is equivalence/biosimilar (something like that) trials. The Dreamboat was not tested on humans... This was and still is against their own rules which Mnkd tried sidestepping with rheir modelization. Do not forget, (supposedly) they had full agreement on the bioequivalence path forward with the FDA (same drug and excipient, just changed delivery device being tested for dosing). Also recall the convicted FDA staff member that bought stock on positive inside FDA reports before Martin sent in his Christmas love letters. Technically you are correct; however it is reasonable to assume the path they took if they had agreement, all indications were that all was OK until Martin spoke up. What other path would a bunch of risk averse bureaucrats take once presented with their own rules. Just another unfortunate turn of events, but one among a very long string of them. |
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Post by dpca10 on Jan 12, 2016 9:32:03 GMT -5
Since we are just killing time waiting for our fate to be decided I'll weigh in.
Who killed Afrezza: The American people
There is zero tolerance in this country for anything that is other than 100% unquestionably safe. The FDA embodies this and if you need proof turn on late night TV and watch the ads roll on asking you to sue your doctor or a drug company.
Being a medical professional I was dumbfounded over the FDA's rejection and subsequently of their onerous testing requirements. In retrospect I shouldn't have been. I've seen this pattern time and time again.
This process and expectation stifles innovation, punishes creativity and makes novel drugs unaffordable.
Mannkind is an illustrative example of what the pharma companies go through on every drug they approve. I think I was naive that a small company could weather more than one or two setbacks.
I focused and still focus on the great promise Afrezza shows, but watching the financial realities of running a embattled pharma company has been sobering experience. I hope they find a solution and Al Mann decides he would rather go down swinging.
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Post by derek2 on Jan 12, 2016 9:41:03 GMT -5
The Dreamboat was not tested on humans... This was and still is against their own rules which Mnkd tried sidestepping with rheir modelization. Do not forget, (supposedly) they had full agreement on the bioequivalence path forward with the FDA (same drug and excipient, just changed delivery device being tested for dosing). Also recall the convicted FDA staff member that bought stock on positive inside FDA reports before Martin sent in his Christmas love letters. Technically you are correct; however it is reasonable to assume the path they took if they had agreement, all indications were that all was OK until Martin spoke up. What other path would a bunch of risk averse bureaucrats take once presented with their own rules. Just another unfortunate turn of events, but one among a very long string of them. The FDA stated that MNKD did not submit their in vireo assay method for discussion and review before re-submission, despite being requested to. See: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdfThe most logical interpretation is that the FDA simply were unwilling to budge on in vitro / in vivo, and MNKD mis-read the situation, mis-communicated it to shareholders, and tried to force the issue by resubmitting and got called out. I believe Afrezza was never slotted for approval; it's just assumption by some who would prefer for an email from a short seller to be all-powerful vs. management not complying with FDA requests. The FDA chemist who is seen as a smoking gun, started a position in MNKD, checked 2 weeks out from approval, and dumped his shares; avoiding a loss. He had done similar with another of the dozen+ companies that he had gone long or shorted, so MNKD was not an exception. The common lore is that he had gone long and suffered a loss; his only one; because the FDA had changed their decision at the very last moment. Not the case. He knew 2 weeks before the CRL that it was coming; the 2nd work day of the new year after Shkreli had written an email about a public FDA policy that everyone knew about - written after hours on Christmas Day. Which makes more sense? 1. The FDA was not going to approve Afrezza since they were following their own policies re: in vitro / in vivo bioequivalence studies, and MNKD had not reviewed their approach with the FDA before resubmission and were thus incomplete in their approach. Martin S wrote an email asking the FDA to do what they were going to do anyway, so his email was irrelevant. He was simply a lucky bystander. 2. The FDA decided to break their own rules and "give MNKD a break", but upon receiving an email from a small-time short investor decided to call an emergency meeting over the Christmas break, collude with hedge funds and reverse their decision; overturning a year of scientific review and recording this change in their internal systems in time for the insider trading chemist to see it on the second day back in the New Year. Seriously - the first is backed up by evidence (SEC complaint against the chemist and FDA briefing documents) and common sense. The second is backed up by a need for a villain. |
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Post by esstan2001 on Jan 12, 2016 9:44:08 GMT -5
Since we are just killing time waiting for our fate to be decided I'll weigh in. Who killed Afrezza: The American people There is zero tolerance in this country for anything that is other than 100% unquestionably safe. The FDA embodies this and if you need proof turn on late night TV and watch the ads roll on asking you to sue your doctor or a drug company. Being a medical professional I was dumbfounded over the FDA's rejection and subsequently of their onerous testing requirements. In retrospect I shouldn't have been. I've seen this pattern time and time again. This process and expectation stifles innovation, punishes creativity and makes novel drugs unaffordable. Mannkind is an illustrative example of what the pharma companies go through on every drug they approve. I think I was naive that a small company could weather more than one or two setbacks. I focused and still focus on the great promise Afrezza shows, but watching the financial realities of running a embattled pharma company has been sobering experience. I hope they find a solution and Al Mann decides he would rather go down swinging. I agree with all that you say except for who killed Afrezza- the FDA does not represent the American people in reality; they represent themselves, and it is their fear of getting tagged with approving an unsafe drug that prevents them from rationally, scientifically assessing the benefit / risk ratio of any new medication. (Just like our Afrezza passion blinds us to rational assessment of Mannkind) |
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