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Post by wsulylecoug on Apr 1, 2019 18:17:37 GMT -5
Just read this on FB. I'm happy to see it, but would have preferred to see it come from them first through a PR. They certainly would have PR'd it if the decision went the other way. Now it just appears to be damage control and the optics of it are poor.
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sky
Lab Rat
Posts: 46
Sentiment: Long
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Post by sky on Apr 1, 2019 18:46:32 GMT -5
Nothing new,it was expected. Good find though.
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Post by fisherman on Apr 1, 2019 19:00:41 GMT -5
If it was not for bad luck, Mannkind would have no luck at all.
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Post by sportsrancho on Apr 1, 2019 19:24:37 GMT -5
I’m just sorry I didn’t read this thread before I read all the others🤣 glad for some clarity.
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Post by patten1962 on Apr 1, 2019 19:35:22 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. They also put it on Twitter.
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Post by sportsrancho on Apr 1, 2019 19:42:41 GMT -5
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. They also put it on Twitter. OK I just went and read the Twitter feed... Holy moly! This is the nicest post, well almost, outside of Jeff’s.
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Post by sportsrancho on Apr 2, 2019 6:01:45 GMT -5
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Post by sportsrancho on Apr 2, 2019 6:02:14 GMT -5
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Post by sportsrancho on Apr 2, 2019 6:02:40 GMT -5
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Post by golfeveryday on Apr 2, 2019 6:54:41 GMT -5
yeah, I don’t understand why Brazil was mentioned in the same message as India by MNKD. Also, how is it possible to go after an expedited timeline, get denied and required to to a clinical study and have it not effect the timeline?
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Post by golfeveryday on Apr 2, 2019 6:55:40 GMT -5
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Post by cretin11 on Apr 2, 2019 12:10:44 GMT -5
yeah, I don’t understand why Brazil was mentioned in the same message as India by MNKD. Also, how is it possible to go after an expedited timeline, get denied and required to to a clinical study and have it not effect the timeline? Exactly what i was wondering too.
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Post by cjm18 on Apr 2, 2019 12:32:19 GMT -5
yeah, I don’t understand why Brazil was mentioned in the same message as India by MNKD. Also, how is it possible to go after an expedited timeline, get denied and required to to a clinical study and have it not effect the timeline? Exactly what i was wondering too. Because they expected to have to do the trials. Their timeline has always reflected that.
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Post by matt on Apr 2, 2019 13:04:21 GMT -5
It is entirely reasonable for the Indian drug agency to insist on more data. Many drugs work differently in groups with differing genetics, and Afrezza also has some unique "human factors" that need to be considered, such as need for temperature controlled storage. If you have ever been in Delhi on a hot day you would not question the need for broader stability studies. However, mostly the regulators are concerned with genetic variations of which there are several for T1 diabetics.
The flip side is that the cost of doing a bridge trial is generally fairly low, not anything close to $200 million. The goal is to demonstrate that the drug works in those of Indian ethnicity similar to way it works in Americans and, if not, to document the differences and adjust instructions for usage accordingly. If an initial trial is large enough (think in terms of 2000 patients per cohort) and enrolls patients from several countries, then some drugs can do without the bridging studies but the original MNKD trials were not that large and was performed in the US, hence the need for a bridging study.
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Post by bigchungus91354 on Apr 2, 2019 13:11:29 GMT -5
It is entirely reasonable for the Indian drug agency to insist on more data. Many drugs work differently in groups with differing genetics, and Afrezza also has some unique "human factors" that need to be considered, such as need for temperature controlled storage. If you have ever been in Delhi on a hot day you would not question the need for broader stability studies. However, mostly the regulators are concerned with genetic variations of which there are several for T1 diabetics. The flip side is that the cost of doing a bridge trial is generally fairly low, not anything close to $200 million. The goal is to demonstrate that the drug works in those of Indian ethnicity similar to way it works in Americans and, if not, to document the differences and adjust instructions for usage accordingly. If an initial trial is large enough (think in terms of 2000 patients per cohort) and enrolls patients from several countries, then some drugs can do without the bridging studies but the original MNKD trials were not that large and was performed in the US, hence the need for a bridging study. How large would you expect a bridge trial to be in India? Costs are lower, but it is still a whole other population. n of a few thousand? $20-50M?
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