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Post by seanismorris on Apr 1, 2019 13:15:11 GMT -5
How much is it? I can tell what is fud on this thread... To be honest I don't know. Someone else was saying $200M but I don't know if this is correct. But I do know the runway will get much shorter if we need to fund another clinical trial. If we could afford to do a clinical study we would have done one in the USA to show something better than the "non inferior" results we have now. I wouldn’t be surprised if both companies walk away from the relationship. There wasn’t a lot of financial commitment from either side. To be honest, I wouldn’t be confident about any data collected in India. I don’t remember if this was MannKind or not, but I remember (vaguely) another trial in India where the drug didn’t everything but cure cancer. I’m exaggerating, but India is as corrupt as they come with regards to results. You want sub 6 results? That will cost a bit more...
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Post by #NoMoreNeedles on Apr 1, 2019 13:37:11 GMT -5
It was a very poor management decision trying to suppress the bad news. Now Wallstreet learned this from a blog!
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Post by letitride on Apr 1, 2019 13:51:56 GMT -5
It was a very poor management decision trying to suppress the bad news. Now Wallstreet learned this from a blog! When was it rejected?
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Post by rayskum on Apr 1, 2019 14:03:00 GMT -5
To be honest I don't know. Someone else was saying $200M but I don't know if this is correct. But I do know the runway will get much shorter if we need to fund another clinical trial. If we could afford to do a clinical study we would have done one in the USA to show something better than the "non inferior" results we have now. I wouldn’t be surprised if both companies walk away from the relationship. There wasn’t a lot of financial commitment from either side. To be honest, I wouldn’t be confident about any data collected in India. I don’t remember if this was MannKind or not, but I remember (vaguely) another trial in India where the drug didn’t everything but cure cancer. I’m exaggerating, but India is as corrupt as they come with regards to results. You want sub 6 results? That will cost a bit more... Sean - I am an Indian and have been a MNKD long for last 4 years. there is corruption in India. No doubt. But not the kind of corruption you are talking about without substantiation. They take these studies seriously.
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Post by mytakeonit on Apr 1, 2019 14:19:21 GMT -5
If that $200M is a correct cost for doing a trial in India ... I say forget it for now. If Brazil accepts Afrezza and MNKD, that's where India will take a second look and probably jump in.
But, that's mytakeonit
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Post by robbmo on Apr 1, 2019 15:00:40 GMT -5
Here are the actual comments. I added (Cipla) to clarify who "the firm" is:
The firm(Cipla) presented their proposal for Marketing authorization of Human Insulin Inhalation Powder with Inhaler in India based on clinical data generated in USA.
The committee noted that the firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial. Accordingly, the firm should submit the protocol for clinical trial for review by the committee.
Also, Mike did mention quite a while ago that the regulatory agency might make us do a local trial, so this shouldn't be news to anyone.
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Post by cretin11 on Apr 1, 2019 15:43:26 GMT -5
If that $200M is a correct cost for doing a trial in India ... I say forget it for now. If Brazil accepts Afrezza and MNKD, that's where India will take a second look and probably jump in. But, that's mytakeonit Why would India reverse their decision based on what Brazil does? If they aren't showing respect for what's been approved in the US, it makes no sense that they would care what Brazil does.
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Post by seanismorris on Apr 1, 2019 16:28:55 GMT -5
I wouldn’t be surprised if both companies walk away from the relationship. There wasn’t a lot of financial commitment from either side. To be honest, I wouldn’t be confident about any data collected in India. I don’t remember if this was MannKind or not, but I remember (vaguely) another trial in India where the drug didn’t everything but cure cancer. I’m exaggerating, but India is as corrupt as they come with regards to results. You want sub 6 results? That will cost a bit more... Sean - I am an Indian and have been a MNKD long for last 4 years. there is corruption in India. No doubt. But not the kind of corruption you are talking about without substantiation. They take these studies seriously. This isn’t the one I was thinking about (below), but I wouldn’t spend any money in India with the hope the data could be used elsewhere. April 2016 “MUMBAI (Reuters) - India’s Alkem Laboratories has been accused by Germany’s health regulator of fudging data on clinical trials of an antibiotic and brain disorder drug, becoming the third Indian firm to be scrutinized since 2014 for suspected manipulation of trial data.” MannKind can’t really fund a trial anywhere at this point. It’s either the data collected by MannKind is good enough, or move on, to try to get approval elsewhere. MannKind isn’t even spending money on new patents as far as I can tell. I also don’t think any Afrezza partner would fund a trial in any country in the world. The risk/reward is poor. I’m assuming no trial could be done for less than 10 million (to reach that conclusion). A Techosphere partner would because they have a lot more to gain... Afrezza = No
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Post by seanismorris on Apr 1, 2019 16:32:32 GMT -5
If that $200M is a correct cost for doing a trial in India ... I say forget it for now. If Brazil accepts Afrezza and MNKD, that's where India will take a second look and probably jump in. But, that's mytakeonit Why would India reverse their decision based on what Brazil does? If they aren't showing respect for what's been approved in the US, it makes no sense that they would care what Brazil does. The best and only hope for India to reverse their decision (that I can see) is the Pediatric Study data. ... I agree what Brazil does is irrelevant. The other thing to consider is India’s decision is based on Afrezza’s cost. They may come up with other explanations, but with public healthcare, I wouldn’t be surprised if that was the “real” reason. If Afrezza showed clear superiority maybe things would be different...
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Post by agedhippie on Apr 1, 2019 16:43:41 GMT -5
Here are the actual comments. I added (Cipla) to clarify who "the firm" is: The firm(Cipla) presented their proposal for Marketing authorization of Human Insulin Inhalation Powder with Inhaler in India based on clinical data generated in USA.
The committee noted that the firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial. Accordingly, the firm should submit the protocol for clinical trial for review by the committee.
Also, Mike did mention quite a while ago that the regulatory agency might make us do a local trial, so this shouldn't be news to anyone. That would be in the earnings call last month. I cleaned up the transcript so it matched the audio: We also are getting regulatory pathway clarity for India, for those of you who may not follow the Company closely, we have one of two ways that this can go through. One is a potential approval based on our current data and then potentially that could result in a post marketing study with Cipla; or they could want us to do a post marketing study, and then file for approval after that. We have a meeting with the authorities there and expect to get clarity on that very shortly.It looks like that committee announcement was the clarity.
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Post by tingtongtung on Apr 1, 2019 17:21:06 GMT -5
Here are the actual comments. I added (Cipla) to clarify who "the firm" is: The firm(Cipla) presented their proposal for Marketing authorization of Human Insulin Inhalation Powder with Inhaler in India based on clinical data generated in USA.
The committee noted that the firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial. Accordingly, the firm should submit the protocol for clinical trial for review by the committee.
Also, Mike did mention quite a while ago that the regulatory agency might make us do a local trial, so this shouldn't be news to anyone. That would be in the earnings call last month. I cleaned up the transcript so it matched the audio: We also are getting regulatory pathway clarity for India, for those of you who may not follow the Company closely, we have one of two ways that this can go through. One is a potential approval based on our current data and then potentially that could result in a post marketing study with Cipla; or they could want us to do a post marketing study, and then file for approval after that. We have a meeting with the authorities there and expect to get clarity on that very shortly.It looks like that committee announcement was the clarity. @aged.. Exactly. This was already discussed as you quoted. No idea why people are so upset and bad mouthing India. When the deal was announced it was praised as the biggest country with lots of potential, and now when they ask for local trial, it becomes a filthy third world country good for nothing :-) Grow up people! Each country is different in terms of population (genetic stuff, etc). So, the drug approval agency of every country has the obligation to make sure the drug is good for its population. So, there is nothing wrong with them asking for a local trial. IMHO. (well, the exception being similar race (?).. I'm guessing that similar grouping would be: {US, Canada}, {Aus, NZ?}, {Europe?}, {China}, {India, SE Asia neighbors}, {Africa}). Please correct me if I'm wrong. The biggest problem with MNKD is lack of execution here in US. It's top heavy, they come up with too many outlandish slogans (embarrassment of riches, veins of gold, etc..). They seem to lack a game plan. They need to fix the insurance. That's the only thing that will get more scripts. The ad is weird, and they just wish that it will work and playing it. They clearly lack the plan. Well, I'm not a marketing person, so I dont know how to do it. But, I think they need to spend all their time working with insurance. Pediatric trials are on-going. But, IMO unless they get the insurance fixed, it will be difficult to bank on pediatric results. We expected STAT to bump up numbers. Clearly it did not. Ads didn't. It must be pretty obvious for MNKD management that it's the insurance that makes or breaks it. I'm not blaming the MNKD management, but they are not doing enough. And they want nice bonus! I'm voting no for that. As I (and others) have been saying, majority of their compensation should be in stocks so they have skin in the game. BTW, thank you UTHR for saving us!
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Post by peppy on Apr 1, 2019 17:21:52 GMT -5
Here are the actual comments. I added (Cipla) to clarify who "the firm" is: The firm(Cipla) presented their proposal for Marketing authorization of Human Insulin Inhalation Powder with Inhaler in India based on clinical data generated in USA.
The committee noted that the firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial. Accordingly, the firm should submit the protocol for clinical trial for review by the committee.
Also, Mike did mention quite a while ago that the regulatory agency might make us do a local trial, so this shouldn't be news to anyone. quote: Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors. my words: wow. I thought we human being were similar, regardless of melanin and eye color/shape. Who knew? Lungs and vascular so different in the human races. What the heck are the confounding factors? I am confounded.
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Post by robbmo on Apr 1, 2019 17:28:04 GMT -5
Here are the actual comments. I added (Cipla) to clarify who "the firm" is: The firm(Cipla) presented their proposal for Marketing authorization of Human Insulin Inhalation Powder with Inhaler in India based on clinical data generated in USA.
The committee noted that the firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial. Accordingly, the firm should submit the protocol for clinical trial for review by the committee.
Also, Mike did mention quite a while ago that the regulatory agency might make us do a local trial, so this shouldn't be news to anyone. quote: Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors. my words: wow. I thought we human being were similar, regardless of melanin and eye color/shape. Who knew? Lungs and vascular so different in the human races. What the heck are the confounding factors? I am confounded. My thought is the "confounding factors" are the potentially large portion of the population who have compromised lung function due to the poor air quality. It was probably the nicest way they could say it without acknowledging a public health crisis. The flip-side would be, if we do a study and prove that it will work in this population, then that barrier would be taken down for other places.
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Post by sla55 on Apr 1, 2019 17:48:04 GMT -5
On Mannkind Corporation Facebook page:
"The decision by the Central Drugs Standard Control Organisation (CDSCO) in India to require a local clinical trial of Afrezza® is consistent with established regulatory practice in India. We supported Cipla’s pursuit of an exemption in order to make Afrezza available sooner to patients in India by leveraging the vast clinical data supporting the US approval of Afrezza. The CDSCO’s decision does not impact our anticipated timeline for regulatory approval in India, nor does it impact the regulatory pathway in Brazil."
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Post by hellodolly on Apr 1, 2019 18:11:21 GMT -5
On Mannkind Corporation Facebook page: "The decision by the Central Drugs Standard Control Organisation (CDSCO) in India to require a local clinical trial of Afrezza® is consistent with established regulatory practice in India. We supported Cipla’s pursuit of an exemption in order to make Afrezza available sooner to patients in India by leveraging the vast clinical data supporting the US approval of Afrezza. The CDSCO’s decision does not impact our anticipated timeline for regulatory approval in India, nor does it impact the regulatory pathway in Brazil."Nice to see them listening to their shareholders and providing some color to India, rather than go dark. Nice find. Well there you have it people.
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