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Post by radgray68 on Dec 28, 2023 10:39:34 GMT -5
You can thank Sanofi for the crippling terms of the Amphastar agreement. It was their insistence that we have it. Maybe after 7 renegotiations we can finally stop the bleeding.
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Post by sayhey24 on Dec 28, 2023 10:47:28 GMT -5
The VGo thingy uses any U-100 fast acting insulin which is a separate prescription which MNKD is not supplying. With any hope 2024 will bring in some changes at MNKD and the VGo thingy will be put back in the dumpster. I see the Amphistar thingy as good news / bad news. On one hand it reduces risk on MNDKs part on required insulin purchases. On the other hand MNKD is reducing purchases rather than increasing which means less anticipated afrezza sales. The Afrezza sales run rate is well established. If it changes enough to worry about needing more insulin, that will be a good problem to have (in 2025 or 2026?). Reducing the cost of the Amphistar obligation in the near term is a good thing. I think the current afrezza sales run rate being well established is the problem. Mike needs focus on this and change it. The kids study will have no impact in 2024 on sales. Hopefully the India study can. Both should position for increased 2025 sales. A study adding afrezza to GLP1s would also help on 2025 sales. Getting afrezza on 2025 Medicare with out pre auths would be huge. |
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Post by agedhippie on Dec 28, 2023 12:31:26 GMT -5
... I'm also confused in sub section (2.2): “Year 1” means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar Twice it's mentioned "FDA approval" starts the clock on this new agreement? I think this is because Amphastar is changing the way they manufacture the insulin (different inclusion bodies). As I understand it this means that MNKD will need to get FDA approval for the change since it's now a different API. The approval is pretty much a formality since Amphastar France is a reputable manufacturer and will have done the work with the FDA to establish equivalence which is what matters. My guess would be that you can get a good handle on the timing from those approval dates in the contract. |
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Post by hellodolly on Dec 28, 2023 13:08:49 GMT -5
... I'm also confused in sub section (2.2): “Year 1” means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar Twice it's mentioned "FDA approval" starts the clock on this new agreement? I think this is because Amphastar is changing the way they manufacture the insulin (different inclusion bodies). As I understand it this means that MNKD will need to get FDA approval for the change since it's now a different API. The approval is pretty much a formality since Amphastar France is a reputable manufacturer and will have done the work with the FDA to establish equivalence which is what matters. My guess would be that you can get a good handle on the timing from those approval dates in the contract. Always appreciate you. |
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Post by sayhey24 on Dec 28, 2023 16:27:58 GMT -5
... I'm also confused in sub section (2.2): “Year 1” means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar Twice it's mentioned "FDA approval" starts the clock on this new agreement? I think this is because Amphastar is changing the way they manufacture the insulin (different inclusion bodies). As I understand it this means that MNKD will need to get FDA approval for the change since it's now a different API. The approval is pretty much a formality since Amphastar France is a reputable manufacturer and will have done the work with the FDA to establish equivalence which is what matters. My guess would be that you can get a good handle on the timing from those approval dates in the contract. Exactly - the approval is a formality but must be done and paperwork submitted. I think as you may have said before it overall an advantage for MNKD and let them reset the purchase requirements. I see this as a very small win for MNKD. Then again, any win for MNKD is IMO huge because at this point I will take anything. |
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