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Post by kimi on Apr 1, 2019 2:29:08 GMT -5
Very, very bad news!
CDSCO rejects Cipla's application for marketing human insulin inhalation powder as SEC makes local trial compulsory
May be for that reason MNKD (and not S3) is down in Germany
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Post by mango on Apr 1, 2019 2:44:34 GMT -5
They want MannKind to do a local clinical trial
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Post by kite on Apr 1, 2019 6:26:28 GMT -5
This was unexpected
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Post by golfeveryday on Apr 1, 2019 6:34:39 GMT -5
probability was high imo. BP’s tentacles reach globally. |
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Post by #NoMoreNeedles on Apr 1, 2019 6:39:56 GMT -5
Brazil next?
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Post by cjm18 on Apr 1, 2019 7:32:45 GMT -5
Mc said fast track was not likely. This was expected.
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Post by radgray68 on Apr 1, 2019 10:31:02 GMT -5
They just HAD to mention Exubera and fear of lung problems. Ignoring ALL we have proved about our drug. So India is just as corrupt or inept as the U.S. Regulators. Great, just...great. There was NO NEED TO MENTION Pfizer at all. Sheesh.
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Post by bigchungus91354 on Apr 1, 2019 10:39:45 GMT -5
They just HAD to mention Exubera and fear of lung problems. Ignoring ALL we have proved about our drug. So India is just as corrupt or inept as the U.S. Regulators. Great, just...great. There was NO NEED TO MENTION Pfizer at all. Sheesh. How much do we estimate it would cost to do a local trial in India? I guessing around $200M US. We would certainly need a partner to move forward with this one, is there any indication that Cipla would agree to absorb that cost? |
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Post by buyitonsale on Apr 1, 2019 11:20:47 GMT -5
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Post by patten1962 on Apr 1, 2019 11:22:13 GMT -5
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Post by mnholdem on Apr 1, 2019 12:02:47 GMT -5
One silver lining is that MannKind can do a superiority trial in India instead of a merely non-inferior outcome and post-trial data can be submitted to the FDA for label upgrade. The CEO should insist that CMO David Kendall be intimately involved in the India trial protocols and trial site training to ensure that Afrezza doesn't get dosed too early before meals. Early dosing in US clinical trials led to excessive hypoglycemic excursions and skewed the trial results. This is a chance to correct that error, so it is essential that the trial site personnel are adequately trained for proper titration and administration of Technosphere Insulin.  |
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Post by uvula on Apr 1, 2019 12:09:28 GMT -5
Except we don't have the money to conduct the trial so it is irrelevant.
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Post by barnstormer on Apr 1, 2019 12:23:12 GMT -5
FDA approval documents, STAT study and the veins of gold publications should be loaded up with Kendall on a flight to New Dehli. This has set us back a year. At the rate of execution on these global approvals the patents will run out before Afrezza is a global success. Time to think outside of the Amgen box Mike and get agressive. Time is not our friend. If you have an important product you can't leave your success in the hands of 3rd rate companies doing business in slowlydeveloping countries. Take the lead. Afrezza is your responsibility don't deligate it to a less powerful organization with little skin in the game.
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Post by sportsrancho on Apr 1, 2019 12:44:13 GMT -5
Except we don't have the money to conduct the trial so it is irrelevant. How much is it? I can tell what is fud on this thread... |
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Post by uvula on Apr 1, 2019 13:04:56 GMT -5
Except we don't have the money to conduct the trial so it is irrelevant. 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. |
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