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Post by straightly on Feb 4, 2018 18:38:03 GMT -5
Aged: I don't think anybody will argue against you that MNKD needs to show Afrezza is superior. Nobody is going to argue with you either that a large scale trial is a way do just that. The only question is: how or where MNKD pay for that? If you ask, I will give you AN answer. Otherwise, I am all ears. Allocate budget out of the next funding raise? Matt would have a better idea than me, but from old filings I would say $2M would do it. Without that trial data we can advertise all we like and not see significant movement. There is still the requirement for the large scale lung safety trial out there, maybe that could be combined with a superiority trial (design it as a superiority trial and have lung safety as a secondary objective for the Afrezza arm). Those are my thoughts. What is your answer? $2M does not sound like a whole lot of money. If it were accurate, it does beg the question why MNKD hasn't done it, as it is such a no brainer. How long does such a study has to be? How much does MNKD need to survive till then? My answer is more drastic and dramatic. I suggest we put our potential in the Chinese for bid. Part of the price is to collect data / run comparison to show superority. Remember that the Chinese gov is already requiring and permitting the safety studies on Chinese population be done on its population as one is marketing its drug. Then we turn around and use that data here in US.
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Post by lennymnkd on Feb 4, 2018 19:03:08 GMT -5
No shortage of subjects (China) as china has the largest number of obese children in the world, as well as more diabetes patients than anywhere else /
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Post by lennymnkd on Feb 4, 2018 19:15:29 GMT -5
On second thought will, the FDA let us use a foreign country for trials give the cultural differences ?
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Post by agedhippie on Feb 4, 2018 19:18:17 GMT -5
STAT is only a 40 person study and only for 4 weeks so I doubt you could get a superiority label from that. The best you will get is an improved time in range label which, while it is worth having, is not going to move the needle much. There is an HbA1c measure as a secondary objective and the HbA1c is what they will want for a superiority trial. However the test is only 4 weeks long and you need much longer to get a meaningful HbA1c result since it raises the question as to whether a result is due to a really bad month (low or high) rolling off the HbA1c or is it the treatment. what is your HbA1c aged? 6.3 on my last visit. Although in fairness over time it fluctuates between 6.2 and 6.7 with it tending to be higher in the summer which is odd because I would have expected it to be the other way around.
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Post by dreamboatcruise on Feb 4, 2018 19:20:43 GMT -5
On second thought will, the FDA let us use a foreign country for trials give the cultural differences ? It is very common to have some patients in FDA approved trials enrolled in foreign countries.
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Post by dreamboatcruise on Feb 4, 2018 19:28:54 GMT -5
No shortage of subjects (China) as china has the largest number of obese children in the world, as well as more diabetes patients than anywhere else / Last statistics I saw the US still had around 5 times higher incidence of diabetes per capita. As I remember the only country in the world worse was Saudi Arabia, but we were darn close. Go USA
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Post by dreamboatcruise on Feb 4, 2018 19:37:25 GMT -5
Allocate budget out of the next funding raise? Matt would have a better idea than me, but from old filings I would say $2M would do it. Without that trial data we can advertise all we like and not see significant movement. There is still the requirement for the large scale lung safety trial out there, maybe that could be combined with a superiority trial (design it as a superiority trial and have lung safety as a secondary objective for the Afrezza arm). Those are my thoughts. What is your answer? $2M does not sound like a whole lot of money. If it were accurate, it does beg the question why MNKD hasn't done it, as it is such a no brainer. How long does such a study has to be? How much does MNKD need to survive till then? My answer is more drastic and dramatic. I suggest we put our potential in the Chinese for bid. Part of the price is to collect data / run comparison to show superority. Remember that the Chinese gov is already requiring and permitting the safety studies on Chinese population be done on its population as one is marketing its drug. Then we turn around and use that data here in US. Amphastar having first right of refusal for the Chinese market does raise a barrier to finding other interested parties willing to do all the due diligence, knowing that whatever they agree to could be snagged out from under them.
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Post by straightly on Feb 6, 2018 1:16:23 GMT -5
$2M does not sound like a whole lot of money. If it were accurate, it does beg the question why MNKD hasn't done it, as it is such a no brainer. How long does such a study has to be? How much does MNKD need to survive till then? My answer is more drastic and dramatic. I suggest we put our potential in the Chinese for bid. Part of the price is to collect data / run comparison to show superority. Remember that the Chinese gov is already requiring and permitting the safety studies on Chinese population be done on its population as one is marketing its drug. Then we turn around and use that data here in US. Amphastar having first right of refusal for the Chinese market does raise a barrier to finding other interested parties willing to do all the due diligence, knowing that whatever they agree to could be snagged out from under them. Not sure how much the first right of refusal will even be relevant, but I can assure you if it were a Chinese entity, especially an semi-governmental entity, Amphastar will not be able to do that. There are so many regulations in China that things can become really weird really fast. The counter par in China will more than likely having a different legal standing than Amphastar, which will make Amphastar as one of foreigh participants, like MNKD, instead of like the Chinese entity. In such scenario, there is no "partner" in the deal for Amphastar to refuse. I am obviously not a international trade lawyer but such a lawyer friend told me that IF MNKD goes to China, there will be MANY things to worry about and this agreement is not one of them. He actually advised not going because the promise of making a lot of money from Chinese's huge population in the long run is likely not going to pan out. But we could shoot for a different goal here: We are after a chance/opportunity/resource to make Afrezza a blockbuster here in the US. Profits from China is a bird in the bush which can be imagined to worth BILLIONS if we success first in US or zero if we do not. Will we be satisfied in a deal where we simply give up that bird for a reasonably safe passage to a blockbuster in US? I can be as greedy as many here, more than what is good to my financial well being, attested by my not selling at $6. But I will be satisfied with the valuation when Afrezza become a blockbuster in US, even if profits from China is zero, or just a little such as manufacturing and supplying Afrezza at a certain profit margin?
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Post by mnholdem on Feb 6, 2018 5:29:43 GMT -5
Amphastar is already in China. They have a plant there with Chinese workers, so they already have more than just a foot in the door...from what I understand, China typically insists that if you're going to sell in China, you must manufacture in China.
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Post by careful2invest on Feb 6, 2018 7:08:10 GMT -5
Amphastar is already in China. They have a plant there with Chinese workers, so they already have more than just a foot in the door...from what I understand, China typically insists that if you're going to sell in China, you must manufacture in China. Amphastar to get us going in China, and Amgen to get us going here in the USA... I would be more than okay with that! GLTA!
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Post by dreamboatcruise on Feb 6, 2018 14:17:50 GMT -5
Amphastar is already in China. They have a plant there with Chinese workers, so they already have more than just a foot in the door...from what I understand, China typically insists that if you're going to sell in China, you must manufacture in China. Amphastar to get us going in China, and Amgen to get us going here in the USA... I would be more than okay with that! GLTA! Nothing is going to happen with Amgen here, so would you be sort of ok if Amphastar ever decides to move with Afrezza in China?
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