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Re: SkiMan85 post# 5384

Saturday, 09/19/2020 10:11:58 AM

Saturday, September 19, 2020 10:11:58 AM

Post# of 13869
Correct Skiman. Band aid it’s one thing to be optimistic, but to be so far from reality helps no one make wise decisions.
Their own PR states that they still have to submit final paperwork and after that expect a response within 30 days. Even then the expectation is that FDA will possibly request more info Or approve the FILE!!! Not the Product - the file.
If the final paperwork was ready they would have said ...”we submitted’ or even ‘is being submitted
within ___ days.‘

I will state again. Approving the file does not mean that Hemostyp will have FDA PMA approval.
That will follow within 180 days. Facts matter.

I’ll check back in a couple weeks to follow up on the status of a previously agreed upon Gentlemen’s bet.