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Post by Deleted on Jul 16, 2021 11:08:22 GMT -5
Appreciate the input Chris.
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Post by radgray68 on Jul 16, 2021 11:11:25 GMT -5
"The first thing we do, let's kill all the lawyers." - Shakespeare, Henry VI
What kind of wacky, litigious world would we live in if the American mob figured out all they have to do is take control over the American bar association? Oops! Is it too late?
What kind of slime would hold up approval of a better treatment? It's gotta be the competition or the usual predatory shakedown that is somehow widely accepted as business as usual. It's shameful. Either are unacceptable to me.
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Post by mango on Jul 16, 2021 12:32:26 GMT -5
Here’s the FDA acknowledgment email for the FOIA request. Hopefully we get somewhere with this, if not, oh well, was worth the try.  The FDA does not know who the petitioner is, as the petition was filed by a law firm that will honor its attorney client confidentiality obligation or risk its legal standing with DC bar. The fact that the petition was filed in this manner diminishes its credibility and screams the type of abuse the FDA loathes. Generally, petitions with merit are offered by known sources who have respected credentials and offer information that is compelling and novel, not rehashed data that has already been considered and found to be lacking. If it makes you feel better, Fight fire with fire. Anyone can petition with a rebuttal to every point made in the Lassman submission, as there is no rule against filing a petition that is supportive of a pending NDA. In the end, petitions mainly create noise, and they no doubt arrive somewhat discredited if they are from anonymous sources with unknown credentials. Heck, even Martin Shkreli signed his own letter and acknowledged he was shorting MNKD in his infamous letter preceding a CRL delay for MNKDs NDA. The target here is UTHR- and the circumstances are vastly different. I doubt that UTHR is losing any sleep over this whatsoever. They tend to do their homework and don’t squander certificates for expedited reviews. This smells like a “Hail Mary” by unethical competitors or hedgies, submitted by a lawyer who acts as a regulatory communication agent on behalf of anyone if the fees are paid and the action is not illegal. The “anonymous” client bears responsibility for the content and I suspect they signed a document attesting that the information is factual. Whether it has persuasive merit is a quite different matter. Besides, safely and effectively helping people with PAH is the objective here. I feel confident that the FDA will keep this foremost in mind when approving the NDA. Thank you for sharing the information, all very good points. What I am hoping does happen is I receive the exhibit contents that are locked, supposedly due to “copyright”. What lies in there may be a direct or indirect clue as to who the client is. |
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Post by hopingandwilling on Jul 16, 2021 14:12:38 GMT -5
For the neophytes who do not understand the chicanery and deception that “major” drug companies undertake to flummox their intended patients with pure BS, I would suggest they read Patrick Radden Keefe’s new #1 Best Seller—Empire of Pain, the sordid and horrific history of the three Sackler Brother whose drug (Oxycontin) lead to 100’s of thousands of drug overdose deaths.
There are those, who of all the thousands of drugs tracked and reported by IMS, the only drug IMS reports false prescription data is apparently Afrezza. Make note—these same Sackler’s founded IMS.
Over decades Purdue Pharma, the Sackler Family’s name was never associated with Purdue—as part of a drug empire that the three brothers and their heirs owned 100% as a private company. Therefore, no public records for the billions of dollars they took out of their ownership position—and placed it in offshore banks. Their name never associated with Purdue—yet their names were etched in stone at every major museum from the United States, Europe and even Asia. Basically, the Sackler operated with a business model that promoted lies, lies, and really big lies—but never admit they were wrong and therefore they were always right. Where have we heard lately about an individual operating with this business model?
Two examples to exemplify the shenanigans the Sackler family hoisted off on the FDA and users of their drugs promoted or created by them.
Story 1 --Pfizer hired the Sackler’s advertising company to create a marketing plan for one of their drugs. The end results were a dazzling print advertisement that identified eight(8) medical doctors that had practices located at various states across the country. Eight medical doctors where they gave glowing testimonials for the Pfizer drug. Eight pillars of their community and they stated the merits of the Pfizer drug—and they gave their address to let people know they were medical doctors. Pfizer, the largest drug company in the United States and they were promoting their drugs with testimonials from “real” medical doctors.
What could be wrong with this amazing public display of how wonderful their drug was, and doctors should prescribe it for their patients? Bear in mind—this glossy advertisement even gave the readers the phone numbers for these doctors. The answer for my question was determined when an enterprising reporter called all eight of the medical doctors---upon dialing the given numbers—amazingly the phones rang and rang—and then the dialer got the notice that the dialed number was not a working number. Eight doctors in an advertisement paid by Pfizer—and none of them had a working phone number. The Sacklers and Pfizer were scamming the public! The doctors were fake!
Story #2. When Oxycontin was approved the claims made and promises made to the FDA and eventual patients came in volumes of lies and no supporting clinical data that proved their claims. The number one claim was Oxycontin was not addictive and if anyone did die based on overdosing it was the user’s fault and they must have been an addict before using Oxycontin. The Sackler story was Oxycontin was a safe drug and if the current dose was not controlling the patient’s pain—they needed a higher dosage of Oxycontin. So, the story was simple—Oxycontin was safe, and if anyone died, it was the user’s fault!
Now jump ahead in the story—after decades, the Sackler brothers were facing a dire situation—the patent for Oxycontin was expiring. What do they do—create a new version that was tamper proof and that got them a new patent—leaving the original formulation losing patent protection and thus subject to generic copies being introduced by competitors! But remember the Sackler brothers had a new drug and patent on the improved version of Oxycontin.
So, what could be wrong with this story that could top the Pfizer scam?
No sooner than Purdue got the FDA approval for the new tamper proof version, they (Purdue) submitted to the FDA a request for them not approving a generic version of the original drug, because Purdue now deemed this version as NOT being SAFE for human use. Two decades and billions of dollars being taken in and then shipped to offshore accounts----the Sackler family admits their original product was UNSAFE and COULD kill users.
Use this information or merely ignore it---the price of Keefe’s book would be a good road map to deception that has and could be used for flummoxing patient’s and stockholders. I am certainly not implying that United Therapeutics Corporation is part of any deception or making misleading claims about any of their products.
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Post by longliner on Jul 16, 2021 16:27:47 GMT -5
For the neophytes who do not understand the chicanery and deception that “major” drug companies undertake to flummox their intended patients with pure BS, I would suggest they read Patrick Radden Keefe’s new #1 Best Seller—Empire of Pain, the sordid and horrific history of the three Sackler Brother whose drug (Oxycontin) lead to 100’s of thousands of drug overdose deaths. There are those, who of all the thousands of drugs tracked and reported by IMS, the only drug IMS reports false prescription data is apparently Afrezza. Make note—these same Sackler’s founded IMS. Over decades Purdue Pharma, the Sackler Family’s name was never associated with Purdue—as part of a drug empire that the three brothers and their heirs owned 100% as a private company. Therefore, no public records for the billions of dollars they took out of their ownership position—and placed it in offshore banks. Their name never associated with Purdue—yet their names were etched in stone at every major museum from the United States, Europe and even Asia. Basically, the Sackler operated with a business model that promoted lies, lies, and really big lies—but never admit they were wrong and therefore they were always right. Where have we heard lately about an individual operating with this business model? Two examples to exemplify the shenanigans the Sackler family hoisted off on the FDA and users of their drugs promoted or created by them. Story 1 --Pfizer hired the Sackler’s advertising company to create a marketing plan for one of their drugs. The end results were a dazzling print advertisement that identified eight(8) medical doctors that had practices located at various states across the country. Eight medical doctors where they gave glowing testimonials for the Pfizer drug. Eight pillars of their community and they stated the merits of the Pfizer drug—and they gave their address to let people know they were medical doctors. Pfizer, the largest drug company in the United States and they were promoting their drugs with testimonials from “real” medical doctors. What could be wrong with this amazing public display of how wonderful their drug was, and doctors should prescribe it for their patients? Bear in mind—this glossy advertisement even gave the readers the phone numbers for these doctors. The answer for my question was determined when an enterprising reporter called all eight of the medical doctors---upon dialing the given numbers—amazingly the phones rang and rang—and then the dialer got the notice that the dialed number was not a working number. Eight doctors in an advertisement paid by Pfizer—and none of them had a working phone number. The Sacklers and Pfizer were scamming the public! The doctors were fake! Story #2. When Oxycontin was approved the claims made and promises made to the FDA and eventual patients came in volumes of lies and no supporting clinical data that proved their claims. The number one claim was Oxycontin was not addictive and if anyone did die based on overdosing it was the user’s fault and they must have been an addict before using Oxycontin. The Sackler story was Oxycontin was a safe drug and if the current dose was not controlling the patient’s pain—they needed a higher dosage of Oxycontin. So, the story was simple—Oxycontin was safe, and if anyone died, it was the user’s fault! Now jump ahead in the story—after decades, the Sackler brothers were facing a dire situation—the patent for Oxycontin was expiring. What do they do—create a new version that was tamper proof and that got them a new patent—leaving the original formulation losing patent protection and thus subject to generic copies being introduced by competitors! But remember the Sackler brothers had a new drug and patent on the improved version of Oxycontin. So, what could be wrong with this story that could top the Pfizer scam? No sooner than Purdue got the FDA approval for the new tamper proof version, they (Purdue) submitted to the FDA a request for them not approving a generic version of the original drug, because Purdue now deemed this version as NOT being SAFE for human use. Two decades and billions of dollars being taken in and then shipped to offshore accounts----the Sackler family admits their original product was UNSAFE and COULD kill users. Use this information or merely ignore it---the price of Keefe’s book would be a good road map to deception that has and could be used for flummoxing patient’s and stockholders. I am certainly not implying that United Therapeutics Corporation is part of any deception or making misleading claims about any of their products. Thanks! Ordered. |
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Post by mnkdfann on Jul 17, 2021 8:50:01 GMT -5
There are those, who of all the thousands of drugs tracked and reported by IMS, the only drug IMS reports false prescription data is apparently Afrezza. Make note— these same Sackler’s founded IMS. I wonder if it may be a little more complicated than that, but Sacklers were certainly involved with IMS. This is an interesting read concerning IMS, it gets into the role of the Sacklers near the end. forward.com/news/359832/the-secret-life-of-the-gay-jewish-immigrant-whose-company-sells-your-medica/I haven't read the book you mentioned, maybe it is talking about the same thing (more or less) regarding IMS. |
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Post by nylefty on Jul 17, 2021 21:17:06 GMT -5
There are those, who of all the thousands of drugs tracked and reported by IMS, the only drug IMS reports false prescription data is apparently Afrezza. Where did that come from? Do you have access to IMS's script numbers? |
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Post by itellthefuture777 on Aug 13, 2021 12:05:16 GMT -5
So..with the Factory inspection completed...all that is left is the FDA to say..approved...between now..and October...hmm..
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Post by boca1girl on Aug 13, 2021 12:51:28 GMT -5
So..with the Factory inspection completed...all that is left is the FDA to say..approved...between now..and October...hmm.. Mike said the formal approval letter for the mfg line won’t be sent for 30 days. So the “waiting” for approval should start Sept 6. |
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Post by neil36 on Aug 13, 2021 13:19:43 GMT -5
www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued Drug Review Steps Simplified Preclinical (animal) testing. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness. The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug). The FDA inspects the facilities where the drug will be manufactured as part of the approval process. FDA reviewers will approve the application or issue a complete response letter.
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Post by itellthefuture777 on Aug 13, 2021 13:47:50 GMT -5
So..with the Factory inspection completed...all that is left is the FDA to say..approved...between now..and October...hmm.. Mike said the formal approval letter for the mfg line won’t be sent for 30 days. So the “waiting” for approval should start Sept 6. Nothing found except just a machine qualification item..a minor issue..shouldn't hold up any train  |
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Post by cedafuntennis on Aug 13, 2021 13:51:17 GMT -5
Mike said the formal approval letter for the mfg line won’t be sent for 30 days. So the “waiting” for approval should start Sept 6. Nothing found except just a machine qualification item..a minor issue..shouldn't hold up any train That is correct. There was a related analyst question asked at the end for which the answer was that it was just a minor validation issue noted which will not impact the timeline. |
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