Quote Originally Posted by Tellafriend View Post
Quote Originally Posted by abrown83 View Post

Sounds like they can provide the FDA with the information they are looking for though.

They requested or are requesting a Type A meeting to resolve the issue.


Sounds like a company w a dozen ees who lack exp filling out govt forms and meeting their requirements. At least I hope so. Covid results wn next two weeks. Fingers crossed.

They just wrapped up an investor call. The CEO took responsibility for making mistakes in forms but noted that other big pharma companies do the same all the time.

The FDA hold up was becuase of the needles that they include with the packaging not the drug it’s self. The FDA has also asked them to try 700MG does up from 350 and is not asking them to restart a whole new trial.

I’m not sure what the stock will do tomorrow and I’m not really concerned either way but that was the best call they have had that I have heard them do in the 3 Months I have been following.

The CEO also slipped up towards the end and said “when we are approved” and then had to go back and say “If”...... sounded like a slip.