Post by dudley on Jun 23, 2015 16:23:00 GMT -5
These extracted quotes from Al keep bouncing around in my head :
"Indeed, some key opinion leaders are saying that Afrezza therapy in early stage type 2 diabetes should slow, probably stop and maybe even reverse type 2 diabetes. Today diabetes is the greatest need in medicine globally."
"Sanofi had already done a great deal of work preparing for the launch -- they started even before we had signed the agreement. They have set up an extensive team for the commercialization and that team is hard at work in planning the launch."
Common sense tells us that Sanofi would have done deep and extensive due diligence before committing to this agreement. $900 Million is a huge amount of money - nearly half of the entire development cost for Afrezza. They would have seen the kinetics and understood the science after deep consultations with Al and the rest of the team. They would have understood that the results of the FDA trials and the labeling fell short of what the medication could actually deliver.
I thought initially the early adopter results might have taken them by surprise - not so sure after mulling it over. The "key opinion leaders" (my guess these are the docs involved in the clinical trials such as Dr. Bode and other specialists) also saw things that led them to believe this could be pivotal in Type 2 therapy and communicated it - (thus leading Al to make that quote - it didn't generate itself out of thin air). Sanofi would HAVE to have been privy to all of this and seen the enormous potential, thus "started planning the launch even before signing the agreement".
NOW tie that into this:
The FDA Modernization Act of 1997 - link
The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use.
The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners.
The FDA allows a firm (in this case obviously Sanofi) to add both peer-reviewed articles and economic impact studies to their arsenal of information. I have felt for some time that Dr. Bode or someone of his ilk would be itching to write something and it would not seem far-fetched that may be underway, sponsored by Sanofi. A single, effective Peer-reviewed article could negate a huge percentage of negative opinions with one blow. A well-presented economic summary could negate insurer resistance to covering the medication. You think one of the largest, savviest, experienced drug companies in the world doesn't know this? Get the article(s) published then file to conduct the trial. A well done article from a respected person or persons espousing the benefits would go a long way toward getting the label changed - of course the trial would have to validate it but it would certainly grease the skids while striking terror into the hearts of the competitors and detractors.
I have always had a hard time believing Sanofi is just stumbling along, learning as they go and hoping for the best. They have vast experience in launching products and undoubtedly have complete knowledge of what Afrezza can deliver. Far more likely they have formulated a very sophisticated game plan that will be unfolding in the coming months as they enter the hard launch phase.
I am throwing this out as supporting the argument there is MUCH more going on behind the scenes than we can know. Mnholdem has postulated ("If Afrezza eventually become recognized as the Preferred treatment for both early diabetes AND as a prandial combined with basal, Sanofi can conceivably capture nearly the entire diabetes market") - thanks mn!!.
Just more food for thought - Sanofi could well be maneuvering to establish themselves as THE dominant player in the global insulin market, with Afrezza as a key element of the plan. That makes a lot more sense to me than spending $200 million already and putting themselves up for another $700 million, then stumbling along only to walk away. They are shrewd and sophisticated operators, not a bunch of amateurs.
"Indeed, some key opinion leaders are saying that Afrezza therapy in early stage type 2 diabetes should slow, probably stop and maybe even reverse type 2 diabetes. Today diabetes is the greatest need in medicine globally."
"Sanofi had already done a great deal of work preparing for the launch -- they started even before we had signed the agreement. They have set up an extensive team for the commercialization and that team is hard at work in planning the launch."
Common sense tells us that Sanofi would have done deep and extensive due diligence before committing to this agreement. $900 Million is a huge amount of money - nearly half of the entire development cost for Afrezza. They would have seen the kinetics and understood the science after deep consultations with Al and the rest of the team. They would have understood that the results of the FDA trials and the labeling fell short of what the medication could actually deliver.
I thought initially the early adopter results might have taken them by surprise - not so sure after mulling it over. The "key opinion leaders" (my guess these are the docs involved in the clinical trials such as Dr. Bode and other specialists) also saw things that led them to believe this could be pivotal in Type 2 therapy and communicated it - (thus leading Al to make that quote - it didn't generate itself out of thin air). Sanofi would HAVE to have been privy to all of this and seen the enormous potential, thus "started planning the launch even before signing the agreement".
NOW tie that into this:
The FDA Modernization Act of 1997 - link
The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use.
The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners.
The FDA allows a firm (in this case obviously Sanofi) to add both peer-reviewed articles and economic impact studies to their arsenal of information. I have felt for some time that Dr. Bode or someone of his ilk would be itching to write something and it would not seem far-fetched that may be underway, sponsored by Sanofi. A single, effective Peer-reviewed article could negate a huge percentage of negative opinions with one blow. A well-presented economic summary could negate insurer resistance to covering the medication. You think one of the largest, savviest, experienced drug companies in the world doesn't know this? Get the article(s) published then file to conduct the trial. A well done article from a respected person or persons espousing the benefits would go a long way toward getting the label changed - of course the trial would have to validate it but it would certainly grease the skids while striking terror into the hearts of the competitors and detractors.
I have always had a hard time believing Sanofi is just stumbling along, learning as they go and hoping for the best. They have vast experience in launching products and undoubtedly have complete knowledge of what Afrezza can deliver. Far more likely they have formulated a very sophisticated game plan that will be unfolding in the coming months as they enter the hard launch phase.
I am throwing this out as supporting the argument there is MUCH more going on behind the scenes than we can know. Mnholdem has postulated ("If Afrezza eventually become recognized as the Preferred treatment for both early diabetes AND as a prandial combined with basal, Sanofi can conceivably capture nearly the entire diabetes market") - thanks mn!!.
Just more food for thought - Sanofi could well be maneuvering to establish themselves as THE dominant player in the global insulin market, with Afrezza as a key element of the plan. That makes a lot more sense to me than spending $200 million already and putting themselves up for another $700 million, then stumbling along only to walk away. They are shrewd and sophisticated operators, not a bunch of amateurs.
