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Re: None

Saturday, 07/16/2022 6:35:22 PM

Saturday, July 16, 2022 6:35:22 PM

Post# of 13869
Positive post coming…I’m not sure why everyone is so shocked by this outcome. On May 24 2022 I wrote:

“I believe even those wearing the thickest of rose colored glasses will read the PR and deduce that UHP is not expecting to leave the meeting with the approval in hand.

Our hope needs to be that they are provided a specific list of hurdles remaining. With that, they can work towards jumping those hurdles in a timely manner.
And if all are crossed successfully approval should be granted on schedule I laid out in post 9247 on May 2nd. “

FDA has. Now provided exactly what I predicted we need in order to move forward in a positive direction.

Though this is not being called an official Approvable Letter DR5 and I had referenced before, it is the next best thing.

My advice is to throw away the timeline predictions and pray that management gets this right. I do believe it’s their last chance. Don’t try to mislead the FDA or your investors going forward. I believe (hope) they have finally realized this and are moving forward in a positive direction.