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Post by jezzyritz on Oct 12, 2017 15:34:05 GMT -5
Hello many of you probably have never seen me.. I am a newbie. I just wanna ask everyone what do you see happening as short term goals of MNKD like next 6 months? And possible long term goals 1+ years? I've done some research on this company just invested after the label change and saw this company's potential is huge.
Thank you!! Look forward to everyone's thoughts!
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Post by dreamboatcruise on Oct 12, 2017 15:57:49 GMT -5
Take a look at the Cantor Global Healthcare Conference presentation from Sept 25th. There's always a lot of wild speculation running around, but it's probably best to get the info straight from management.
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Post by mnholdem on Oct 12, 2017 16:56:28 GMT -5
Hello many of you probably have never seen me.. I am a newbie. I just wanna ask everyone what do you see happening as short term goals of MNKD like next 6 months? And possible long term goals 1+ years? I've done some research on this company just invested after the label change and saw this company's potential is huge. Thank you!! Look forward to everyone's thoughts! From a recent company presentation:
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Post by dreamboatcruise on Oct 12, 2017 17:51:59 GMT -5
We've had (or very soon to have) three things that fall under this list since then.
- Big step in recap
- Label change
- Submission for regulatory approval in Brazil (stated by Mike as happening within a few days). That's one, whereas list indicates plural announcements.
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Post by mnholdem on Oct 12, 2017 18:23:17 GMT -5
Mike stated on his Wharton radio show interview that regulatory filings for approval of Afrezza in countries that hold 50% of the world's population will be completed within 12 months.  |
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Post by dh4mizzou on Oct 12, 2017 18:27:53 GMT -5
Mike stated on his Wharton radio show interview that regulatory filings for approval of Afrezza in countries that hold 50% of the world's population will be completed within 12 months. Did you get the impression that the "filings" would be done in 12 months or that the "approvals" could be done by then? |
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Post by sportsrancho on Oct 12, 2017 18:28:41 GMT -5
So then we should be pretty much world wide by 2019.
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Post by Deleted on Oct 12, 2017 20:15:04 GMT -5
So then we should be pretty much world wide by 2019. I dont about world wide. My doctor friend here in Japan said that you can expect another 3 to 5 years for approval here. Do to a very conservative medical system. I hope there was something lost in translation. |
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Post by dreamboatcruise on Oct 12, 2017 20:50:21 GMT -5
Mike stated on his Wharton radio show interview that regulatory filings for approval of Afrezza in countries that hold 50% of the world's population will be completed within 12 months. Did you get the impression that the "filings" would be done in 12 months or that the "approvals" could be done by then? He said "file" in the interview. |
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Post by cjm18 on Oct 12, 2017 20:58:04 GMT -5
Only China and India have more diabetics than USA. Then again they have 2.6 billion of worlds 7.6 billion population.
For mikes statement about 50% to be true it seems India and china have to be included. Add in uae, Brazil, and USA.
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Post by dreamboatcruise on Oct 12, 2017 21:05:12 GMT -5
Only China and India have more diabetics than USA. Then again they have 2.6 billion of worlds 7.6 billion population. For mikes statement about 50% to be true it seems India and china have to be included. Add in uae, Brazil, and USA. The countries are shown in the slides from the Cantor presentation on Sept 25. Yes, all those you mentioned are included. Bear in mind % population does not at all correspond to % of pharma market revenue potential, however. |
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Post by invn00b on Oct 13, 2017 8:00:51 GMT -5
So then we should be pretty much world wide by 2019. Highly unlikely they will tap into the Chinese market by 2019. China has just announced a potential regulatory pathway for review of clinical data that was not generated in China but with no imminent implementation date. Even if their existing data can be used you're still looking at a 12-18 month timeline for approval. The diabetes market in China is huge but MK will be met with the same resistance as the US market as far as product adoption. The globalization strategy timeline should be considered extremely long-term and product adoption will likely only happen once it begins to take off in the USA. Other geographies tend to follow suit from a regulatory and reimbursement perspective only after the products are perceived well in other major markets. The rewards for their efforts will be huge but from a risk and timing perspective this is no short term endeavor. |
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Post by straightly on Oct 13, 2017 8:35:58 GMT -5
So then we should be pretty much world wide by 2019. Highly unlikely they will tap into the Chinese market by 2019. China has just announced a potential regulatory pathway for review of clinical data that was not generated in China but with no imminent implementation date. Even if their existing data can be used you're still looking at a 12-18 month timeline for approval. The diabetes market in China is huge but MK will be met with the same resistance as the US market as far as product adoption. The globalization strategy timeline should be considered extremely long-term and product adoption will likely only happen once it begins to take off in the USA. Other geographies tend to follow suit from a regulatory and reimbursement perspective only after the products are perceived well in other major markets. The rewards for their efforts will be huge but from a risk and timing perspective this is no short term endeavor. Wrong. This is China. With this announcement, the "implementation" started the same time and SOME medications are already on its way for approval, fast! Resistence will NOT be from MK. We need to find somebody who know where the pathways are. Here is the hope we will be one of the drugs go through with this policy. China will proudly say that "A life saving/improving drug cannot make its way in US find a second life in China" and it still have time to do it. Think cellphone and internet if you want an example of MK resistence. |
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Post by invn00b on Oct 13, 2017 8:50:51 GMT -5
Highly unlikely they will tap into the Chinese market by 2019. China has just announced a potential regulatory pathway for review of clinical data that was not generated in China but with no imminent implementation date. Even if their existing data can be used you're still looking at a 12-18 month timeline for approval. The diabetes market in China is huge but MK will be met with the same resistance as the US market as far as product adoption. The globalization strategy timeline should be considered extremely long-term and product adoption will likely only happen once it begins to take off in the USA. Other geographies tend to follow suit from a regulatory and reimbursement perspective only after the products are perceived well in other major markets. The rewards for their efforts will be huge but from a risk and timing perspective this is no short term endeavor. Wrong. This is China. With this announcement, the "implementation" started the same time and SOME medications are already on its way for approval, fast! Resistence will NOT be from MK. We need to find somebody who know where the pathways are. Here is the hope we will be one of the drugs go through with this policy. China will proudly say that "A life saving/improving drug cannot make its way in US find a second life in China" and it still have time to do it. Think cellphone and internet if you want an example of MK resistence. Just my pragmatic and humble opinion as a person with global regulatory affairs experience for drugs and medical devices. You could be right, but I don't understand the incentive for China to do as you say. China's first priority is China and the CFDA focuses its efforts on products developed or manufactured on their home turf or products proven elsewhere to be a slam dunk to benefit their population. Again, JMHO and I hope things move quicker than I expect as i'm invested in this too... |
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Post by peppy on Oct 13, 2017 9:00:30 GMT -5
Wrong. This is China. With this announcement, the "implementation" started the same time and SOME medications are already on its way for approval, fast! Resistence will NOT be from MK. We need to find somebody who know where the pathways are. Here is the hope we will be one of the drugs go through with this policy. China will proudly say that "A life saving/improving drug cannot make its way in US find a second life in China" and it still have time to do it. Think cellphone and internet if you want an example of MK resistence. Just my pragmatic and humble opinion as a person with global regulatory affairs experience for drugs and medical devices. You could be right, but I don't understand the incentive for China to do as you say. China's first priority is China and the CFDA focuses its efforts on products developed or manufactured on their home turf or products proven elsewhere to be a slam dunk to benefit their population. Again, JMHO and I hope things move quicker than I expect as i'm invested in this too... quote: the incentive for China to do as you say. China's first priority is China reply: agreed. somehow some benefit to china is needed. it would have to be monetary, or patent, I would think.
Mike did say, everyone gets their cut along the distribution chain.
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