Outlook Therapeutics Inc (OTLK)

[H2R]

Seeking Alpha: Positive Article

https://seekingalpha.com/article/4681360-outlook-therapeutics-de-risked-regulatory-tracks-are-lining-up-for-possible-ons-5010-approval

The article recaps most of the latest developments fairly well. I copied the conclusion below:

Outlook Therapeutics has done well to advance its lead program in its pipeline, which is the use of ONS-5010 for the treatment of patients with Wet age-related macular degeneration [Wet-AMD]. It has already de-risked this asset on two fronts, which would be on possible U.S. and European approvals. With respect to possible U.S. approval of this drug, it is all going to depend upon what the final results from the phase 3 NORSE EIGHT study are going to be. That is, upon whether or not the primary endpoint of BCVA is going to be met with statistical significance in this trial.

However, I believe that an even better opportunity lies with respect to European approval. Why is that? That's because the EC didn't require another study for potential ONS-5010 approval. Not only that, but the CHMP has already pretty much given a positive opinion on it. This doesn't mean that European approval is guaranteed to happen, but it greatly increases the odds of it. With several catalysts on the way in 2024, plus continued regulatory advancement of ONS-5010 on two fronts, I believe that investors could benefit with any potential gains.

That sums it up pretty well.

Best of luck with your investments!