|
|
Post by Clement on Aug 9, 2024 7:51:02 GMT -5
Slide 27 from the EC mentions MNKD will present at the 8th Annual IPF Summit in August. What information does MNKD have to present?
|
|
|
|
Post by sayhey24 on Aug 9, 2024 11:09:45 GMT -5
Slide 27 from the EC mentions MNKD will present at the 8th Annual IPF Summit in August. What information does MNKD have to present? They are presenting on 8/31 at 4pm. They have not yet announced what they are presenting. UTHR is presenting at 5pm on the Tyvaso DPI trial design. If I were to guess they could be presenting on the benefits of Technosphere and its use with Tyvaso and how they are using it with MNKD-201. Maybe it will start a conversation with Matt Thomas from Boehringer Ingelheim. |
|
|
|
Post by agedhippie on Aug 9, 2024 13:30:02 GMT -5
sayhey24 - I don’t like to dwell on cost and insurance, but those are still important hurdles. I don’t know how much Afrezza costs to make, so I don’t know how much product would have to sell to be able to drop the price close to cost and make up the difference in volume, but I hope it’s low enough for Afrezza to be sold at a low premium to RAA (less than twice as much?). I don’t know what the sweet spot is there or how to reach it (maybe pilot pricing in regions?) but I think its critical. I think you are going in the opposite direction to Mike  "Afrezza net revenue of $16 million grew 20% versus second quarter 2023 which was primarily driven by volume growth, a lower gross to net percentage of 37% versus 39% in the prior year, and a price increase." MNKD aren't reducing the price of Afrezza, they are increasing it. |
|
|
|
Post by sayhey24 on Aug 9, 2024 13:39:18 GMT -5
^^^. Nice summary. sayhey24 - I don’t like to dwell on cost and insurance, but those are still important hurdles. I don’t know how much Afrezza costs to make, so I don’t know how much product would have to sell to be able to drop the price close to cost and make up the difference in volume, but I hope it’s low enough for Afrezza to be sold at a low premium to RAA (less than twice as much?). I don’t know what the sweet spot is there or how to reach it (maybe pilot pricing in regions?) but I think its critical. I think Mike thinks he will get insurance. Lets hope. I think this is Mike way of saying they are over the hump and addressing; label; SoC; and cost. Lets hope "Finally, we will have proper data readouts, proper label updates, and now we have a capital and talent to continue to scale this business." At one point he thanked the patience of the shareholders. |
|
|
|
Post by agedhippie on Aug 9, 2024 13:40:05 GMT -5
... Gestational This will show superiority as long as the future moms dose properly. ... It will show superiority as they have scoped it to just a standardized meal test over the first two hours and they have done that trial several times before. This trial is about showing that Afrezza is safe to use during pregnancy (currently it's not approved if you are pregnant.) I don't see this trial have much impact in itself (all the insurance issues will still apply), but what it will do is unlock the second trial comparing Afrezza and RAA over a longer period - the trial Carol Levy wants to do. The longer trial could change insurance cover for pregnant women. |
|
|
|
Post by sayhey24 on Aug 9, 2024 14:08:21 GMT -5
... Gestational This will show superiority as long as the future moms dose properly. ... It will show superiority as they have scoped it to just a standardized meal test over the first two hours and they have done that trial several times before. This trial is about showing that Afrezza is safe to use during pregnancy (currently it's not approved if you are pregnant.) I don't see this trial have much impact in itself (all the insurance issues will still apply), but what it will do is unlock the second trial comparing Afrezza and RAA over a longer period - the trial Carol Levy wants to do. The longer trial could change insurance cover for pregnant women. Label updates are the goal along with 250,000 patientsl. Carol just wants another pay day. We already know afrezza beats RAAs when dosed properly and human insulin has no safety concerns. |
|
|
|
Post by agedhippie on Aug 10, 2024 11:09:14 GMT -5
|
|
|
|
Post by prcgorman2 on Aug 10, 2024 15:28:24 GMT -5
Yup. No such thing as “no safety concerns”, but it would be fair to claim less safety concern because of the ultra-rapid action of in-AND out. The risk of overdosing with Afrezza is probably provably less than the risk of overdosing when stacking RAA, especially in combination with basal. I have to wonder how many elderly people (if they make it to being elderly) succumb to accidental overdose of conventional basal and RAA insulin.
|
|
It's insulin.