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Post by mnholdem on Jun 19, 2017 17:46:04 GMT -5
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Post by centralcoastinvestor on Jun 19, 2017 22:22:43 GMT -5
I read through the slides. I was confused on what the timeline might be. It looks like 6 months is the most likely timeframe. Anyone else seeing this?
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Post by mnkdfann on Jun 19, 2017 22:33:01 GMT -5
I read through the slides. I was confused on what the timeline might be. It looks like 6 months is the most likely timeframe. Anyone else seeing this? I'm also confused. The timelines appear to be for drugs that are approved all the way through. But it notes that ANVISA only approves 41% (?) of studies? And that 98% of projects sent to CONEP had pending issues? I don't know what to make of that, so I don't understand how it all fits together. The slides are also from a 2006 conference, so are they still even relevant? |
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Post by compound26 on Jun 19, 2017 22:57:51 GMT -5
I read through the slides. I was confused on what the timeline might be. It looks like 6 months is the most likely timeframe. Anyone else seeing this? There was someone from Brazil made a comment on the Afrezza facebook group stating that "Afrezza's arrival forecast is until the end of 2017". www.facebook.com/groups/1491153011166114 |
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Post by kuka on Jun 20, 2017 2:21:07 GMT -5
Afrezza is Human Insulin. Insulin Already approved in other forms so this is not a new drug. Suspect this will be a fast approval since Brazil has a HUGE diabetes problem. The Brazilian company prob has some government connections as well.
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Post by sportsrancho on Jun 20, 2017 6:35:29 GMT -5
I read through the slides. I was confused on what the timeline might be. It looks like 6 months is the most likely timeframe. Anyone else seeing this? There was someone from Brazil made a comment on the Afrezza facebook group stating that "Afrezza's arrival forecast is until the end of 2017". www.facebook.com/groups/1491153011166114 Very interesting comments on the FB link. |
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Post by mydogskip on Jun 20, 2017 7:16:15 GMT -5
Afrezza is Human Insulin. Insulin Already approved in other forms so this is not a new drug. Suspect this will be a fast approval since Brazil has a HUGE diabetes problem. The Brazilian company prob has some government connections as well. Fast Approval? If you mean ~8-9 months then sure. Brazil's government, like many SA governments are typically mired in red tape and inefficiencies. The only way things get done quickly is when a government official is bribed. Better hope Biomm knows what hands to grease. |
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Post by mnholdem on Jun 20, 2017 7:25:11 GMT -5
How does the drug approval process work in Brazil? Sep 13, 2016 · by Felipe Argolo, M.D. Medicine and Healthcare, Federal University of Bahia (2016)
Drug approval for Brazil works through Agência Nacional de Vigilância Sanitária which general is known as ANVISA.
In short, one can use the same common technical document (CTD) used to submit to all of the other health authorities. Module 2–5 is generally the same for every country (again, with the exception of the FDA, EMA, and PMDA). The only difference for the ANVISA application is that you’ll need to update Module 1 which contains the regional specific package which generally includes details like how the product would be shipped to the country, the product information, and how it gets release tested. Generally, only Module 1 gets translated into the local language (in this case, Portuguese). Again, this won’t be the case for the PMDA.
ANVISA does have a request for additional studies. Because of the local climate, Brazil wants to see additional drug stability data (which is used to determine the drug shelf-life) at 30C and 75% relative humidity.
And that’s that. Approval generally takes 9 months.
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Post by matt on Jun 20, 2017 7:35:29 GMT -5
The slides you linked to show what happens for an investigational drug, which Afrezza is not at this point. That process is what is needed to start a study on an experimental drug, not to import an already approved drug.
Brazil follows the Common Technical Document (CTD) format, which has five modules. Modules 2-5 are the same for most countries so essentially no work is involved with a submission. Module 1 has all the regional information, such as label copy, all of which is translated into Brazilian Portuguese. Despite Brazil accepting the quality tests from Module 3, they do require additional stability testing in conditions that mimic the hot and humid jungle climate in Brazil. FDA and EMA specify the temperature / humidity ranges for stability testing, but unless the sponsor has thought about this in advance they will not have the necessary data for Brazil. That takes time to develop.
The approval process seems to average about nine months once the complete CTD is submitted, and obviously the translation and additional studies have to be included. Most countries will allow submission module by module, so modules 2,4, and 5 can be submitted immediately while translation (module 1) and stability (module 3) are finished. Realistically, I would be thinking in terms of a year as the minimum time line.
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Post by peppy on Jun 20, 2017 7:38:36 GMT -5
30C and 75% humidity reminds me of Matt B's testing in a greenhouse in Australia. Very hot in Australia. Brazil, the equator knocking on their heads.
Extreme Storage challenge.
afrezzadownunder.com/
During the early stages of Afrezza’s development, it was claimed that it could go without refrigeration for more than two months. However, the packaging instead says to only store at room temperature for 10 days. This extreme test goes 16x longer than the labelling to see how it still performs.
Since starting on Afrezza I have been wondering if Afrezza really does require refrigeration. As you will see in the video, where I stored the insulin was certainly much warmer than average room temperature.
The blister pack spent 161 days without refrigeration before this test. It was first put in the heated hothouse on August 22nd, and then taken out on December 5th (105 days). After that, it spent 56 days in the hottest room in my house during a typically hot Australian summer. Melbourne had 20 days above 90° F (32.2° C), and 5 days above 100° F (37.8° C) during the test period.
Unlike the US, summer officially starts in Australia on December 1st. For an official temperature record of Melbourne over this period, visit this Bureau of Meterology page.
To test if Afrezza still worked, I used a can of Australian full strength Coke, (which has sugar as 100% sucrose in Australia). Sucrose and caffeine together make this drink raise glucose levels quickly. A control test using newly-ordered Afrezza stored in the fridge was also conducted (video will be uploaded soon). Basal insulin was the amazing Tresiba, and no food or other insulin had been taken prior to the tests.
Long story short, there was NO decrease in Afrezza’s efficacy after the five months. It worked flawlessly and glucose never left the non-diabetic levels. Glucose started at 4.2 mmol/L (75 mg/dL) and ranged from 3.8 mmol/L (68 mg/dL) to 4.6 mmol/L (83 mg/dL) during the test. I certainly won’t be requesting refrigerated shipping from the US anymore.
The significance of this really can’t be overstated. The Frio insulin cases we use when travelling barely work in tropical humidity. For diabetics who travel frequently, those who live in hot climates, or anyone who doesn’t want a fridge packed full of insulin, this is a game-changer.
Put simply, Afrezza does not need refrigeration and there is no other insulin on the market that can make this claim
www.afrezzajustbreathe.com/
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Post by cjm18 on Jun 20, 2017 9:23:06 GMT -5
So... no money to be made from brazil before we run out of money. This thread could be called why shorts don't cover. Hopefully getting afrezza approved in UAE 🇦🇪 is faster.
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Post by silentknight on Jun 20, 2017 9:42:46 GMT -5
So... no money to be made from brazil before we run out of money. This thread could be called why shorts don't cover. Hopefully getting afrezza approved in UAE 🇦🇪 is faster. There's no money to be made from Brazil for what looks to be at least a year, if not more. Assuming a 9 month review process (based on what has been shared in this thread), it will likely take a minumim of 6 months more to finally reach the market there. I'm guessing the same would be said for UAE. Best case scenario, even if the drug was submitted for approval today (which it hasn't apparently), there would probably be several months lead up to market availability, even if they accept FDA approval. It takes time to work out distribution channels and sales for the drug in foreign territories. MNKD's existing cash will run out long before any foreign sales money begins to hit the coffers. That being said, if the company can find a way to last another year, they may finally see some profitability, assuming Afrezza takes hold in foreign markets to a degree greater than what we've seen in the U.S. That is still yet to be determined. |
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Post by deaner3 on Jun 20, 2017 9:50:24 GMT -5
There is no doubt that the company will last another year. Why is that even a thought. Dilution is worst case scenario. And that extends runway long enough for us and other foreign sales to gain ground
But that is the worst case scenario here imo
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Post by silentknight on Jun 20, 2017 10:15:04 GMT -5
There is no doubt that the company will last another year. Why is that even a thought. Dilution is worst case scenario. And that extends runway long enough for us and other foreign sales to gain ground But that is the worst case scenario here imo Even if they diluted to the maximum extent under the authorized share count, at the current price, they'd recoup little more than $60 million or so, which would only buy a few months of operating expenses (not to mention the haircut the stock would take in the process for a dilution of that level). 140 million authorized vs. 101 million issued. To do anything additional would require shareholder approval to increase the authorized share count even more and frankly, I'm doubtful the Mann Group would go for it, considering how much money they've lost already on MNKD. It would certainly give me pause if as the principal shareholder, a company asked me to go along with diluting my investment to that extent after I've already lost billions previously. That of course, is worst case scenario. I certainly hope dilution won't not be necessary and they can find financing of some kind before long, but we've seen already how they've paid off debt with equity a few months ago, after indicating that dilution wasn't something they were looking into. Another debt payment is due to Deerfield again before long. If they pay it again with equity, that only lessens the amount of stock they would have to sell to dilute if necessary. |
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Post by anderson on Jun 20, 2017 10:24:21 GMT -5
There is a fast track for FDA approved drugs. Also the stability test doesn't hold water due to the fact that it has a refrigeration requirement already. That test would only need to be done if there was no refrigeration requirement.
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