ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Silvr, Easka, you may already be ware of the process, but I noticed upon looking at various trial result submissions, it looks like when results are submitted, it won't show that the trial has been updated. However, when you look at the results tab, it will show Results Submitted on the tab. When you open the tab you will see the the 1st Cycle submission and will have to be regularly check it to see if it was sent back with comments from the QC review. This could take time, as there will be a lot of data to review. I figure one month may be longer. Then I have also seen delays in approximately a month before the results get posted, even after meeting QC guidelines on the first attempt. It could take over two months to see it posted, if everything is done right when first submitted.

I also learned that if they fail to submit by October 27, 2023, there is an enforcement process, with a letter being sent giving them 30 days to comply, followed up by a $10,000 per day fine while non-compliant. I figure this would only hinder their chance in any NDA filing. Some have submitted results after the two years without repercussions, but they had ongoing trials and were permitted to delay further to maintain the integrity of the ongoing blinded trials. That does not seem to apply for the Libigel safety/efficacy study.

I figure that if they don't make the splash in the lead up to American Heart Association Scientific Sessions running Nov. 11–13, 2023, they will likely make the splash in the New Year in the lead up to the The 42nd Annual Healthcare Conference will take place on January 8-11, 2024 in San Francisco, CA. Which they claim is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

In the meantime, we will be keeping an eye on the trial results tab.

GLTA