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Re: bluebird50 post# 9843

Friday, 07/15/2022 4:10:38 PM

Friday, July 15, 2022 4:10:38 PM

Post# of 13883
BB you’re new here, but you will soon learn there are no small hurdles when it comes to manufacturing.
As I’ve addressed previously, UHP moved manufacturing post human trials. Hence, they needed to prove they could make the identical product here, with equal raw materials in a factory meeting FDA standards.
UHP failed to disclose the move to FDA in a timely manner which meant the initial process for approval was on dated/inaccurate information.
Therefore, they we’re required to submit a major amendment ( as I’ve outlined and unfortunately been forced to debate here)
The amendment was filed poorly and incomplete by FDA standards which resulted in yet more wasted FDA time.
This PR proves my previous points, and clearly the FDA is saying “ get your manufacturing facts in order and we’ll get this thing APPROVED! But please stop screwing around. “
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