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Re: rodman post# 4700

Friday, 04/17/2020 9:35:31 AM

Friday, April 17, 2020 9:35:31 AM

Post# of 13978
We were “within 30 days of approval” ???
We don’t even know if our paperwork was completed to FDA standard or accepted for further review.
As Last filing said- OUR PMA is on hold.
FDA is still approving non Covid related applications on weekly basis. At about 70 percent of last years week over week rate. But OURS is on hold. Likely because it wasn’t far enough along the approval stages to justify the resources.


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