Apr. 4 at 5:45 PM
$IXHL My understanding of Dreamzz:
1, I believe this is not mandatorily required by FDA, as management has repeatedly stated in news releases that it was the company’s own selection.
2, Dreamzz is added to optimize the two APIs' ratio and the overall dosing. I believe FDA did show such considerations during its review of the P2 data package.
3, To address the FDA’s concerns, IXHL could choose to design a more complex and comprehensive P3 trial without using Dreamzz as a crossover bridge. However, this would prolong the P3 timeline and increase both uncertainty and costs.
4, With Dreamzz added as a key de-risking step, the P3 trial will be much simpler, more efficient, and more straightforward.
5, Regardless of who originally pushed for this crossover study or who will ultimately conduct it (in the event of a strategic transaction), Dreamzz has already been reviewed and approved by the FDA. It is now embedded in the development pathway and can't be removed.
