Found this on yahoo . This poster has intimate kno
Post# of 155188
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Posted On: 07/16/2020 11:50:49 PM
Found this on yahoo . This poster has intimate knowledge of the fda process . Jean is the poster
Let's deconstruct the call a little. Be Bullish my friends. Been doing regulatory affairs for more than 2 decades. On the manufacture issue, this happens a lot. Critical to remember that the review did not question any stability issues, product quality, etc. The Manufacture had to do with co-packaged syryinges and needles. One way around this is to drop any copackaged syringe/needle from approval package, let docs use their own. This means CYDY will ahve just the vial. So this is easily correctable. No absolute need to have a "kit" of the vial + syringes. Also, every needle/syringe is FDA approved under the Med Device category Class II. So this is pretty easy. Appears that CYDY didn't put the details in the package. Easily correctable because every med device company will provide the data and/or provide a Right of Reference authorization letter.
On the clinical side: FDA did NOT ask for new trial; new methodology; new anything. Rather only asked for the updated data in ongoing trials. Important to remember that the actual Trials are now done as of June 2020. Now every patient in a "follow up" trial. that is, the trials are completed and need not be done again. Aggregating data is a common thing. If FDA knows about ongoing trials, they ask for the ongoing data. Happens all the time.
No clinical issues with methodology, patient enrollment numbers, lack of suitability controls; no questions on validation assays; data tables provided as being questionable or lacking credibility. In other words, CLINICALS LOOKS GOOD.
Let's deconstruct the call a little. Be Bullish my friends. Been doing regulatory affairs for more than 2 decades. On the manufacture issue, this happens a lot. Critical to remember that the review did not question any stability issues, product quality, etc. The Manufacture had to do with co-packaged syryinges and needles. One way around this is to drop any copackaged syringe/needle from approval package, let docs use their own. This means CYDY will ahve just the vial. So this is easily correctable. No absolute need to have a "kit" of the vial + syringes. Also, every needle/syringe is FDA approved under the Med Device category Class II. So this is pretty easy. Appears that CYDY didn't put the details in the package. Easily correctable because every med device company will provide the data and/or provide a Right of Reference authorization letter.
On the clinical side: FDA did NOT ask for new trial; new methodology; new anything. Rather only asked for the updated data in ongoing trials. Important to remember that the actual Trials are now done as of June 2020. Now every patient in a "follow up" trial. that is, the trials are completed and need not be done again. Aggregating data is a common thing. If FDA knows about ongoing trials, they ask for the ongoing data. Happens all the time.
No clinical issues with methodology, patient enrollment numbers, lack of suitability controls; no questions on validation assays; data tables provided as being questionable or lacking credibility. In other words, CLINICALS LOOKS GOOD.
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