Except none of those studies were conducted by PAR, so PAR...

Except none of those studies were conducted by PAR, so PAR cannot use any of them when applying for approval unless they go down the Section 505(b)(2) pathway, but they need their own results first before they can make a request to bridge to other results. In other words, these other studies help derisk the heart failure program.

If PAR can confirm these findings in other animals and get confirmation from the FDA on the 505(b)(2) pathway, then they can fast track directly and start phase 2b trials, since they already have all of the data they need in this years IND submission. Not only that, but they can also apply for accelerated approval either prior to or after iPPS approval for OA.

@vaxjopies the alpha was 10%, so in this case significance is reached if p<0.1. PAR needs to do a lot more work, but my guess is they will pursue the heart disease program further.