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Re: None

Friday, 03/27/2020 9:59:14 AM

Friday, March 27, 2020 9:59:14 AM

Post# of 144815
And waggs should have Facet file the IND as soon as its completed...let's get it behind us!

"We do not need to complete the entire 24-month Stability Study to complete and submit the IND to the FDA.  Our regulatory consultant advises us that we will need three months of data from the Stability Study, which is already underway, to include in the IND and not the entire 24 months’ worth of data.  In terms of the CCI test, we have been advised that it would be good to have 3 months of data by the time we submit the IND, but if we’re ready to submit the IND and the CCI test is simply underway, we may be given some leeway by the FDA with the understanding that that three months of data will be available during the 30-day review period of our IND submission by the FDA."
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