Ann: Security Class Reinstatement to Quotation- OPTOB, page-570

I believe we already have a hint of this data

The Sep 2024 Opt update had this slide




• Masked data from patients that have completed the week 52 visit in the ongoing Phase 3 clinical trials show greater mean BCVA increases frombaseline than results with standard of care anti-VEGF-A monotherapy from Opthea’s Phase 2b study**

**Masked data represent pooled data from both sozinibercept combination and standard of care monotherapy treatment arms. The Phase 3 clinical trial masked data are incomplete and subject to additional analysis once unmasked. There is no assurance that standard of care monotherapy in our Phase 3 clinical trials will yield similar results to our prior clinical trials or previously published clinical trials with anti-VEGF-A monotherapies. As a result, there can be no assurance that topline results for sozinibercept from the Phase 3 clinical trial, if completed, will be consistent with results from masked data available to date.

So, we have masked data from the 52-week visit, and it shows better results than standard VEGF-A mono. This would require at least a modest p-value to support such wording—otherwise, they wouldn’t have phrased it the way they have.

What remains unclear, of course, given the masking, is how many letters of improvement we’re talking about. What we do know is that, even with masking, the data at week 52 outperforms the control/sham arms of the Phase 2b trial.

Now, once the masking is dropped and we get the full statistics, I’m 80–90% confident we’re going to see an improvement of 3+ letters. Furthermore, I’d estimate there’s about a 50% chance we’ll see an improvement of 5+ letters.

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How do you and others interpret this data? There’s nothing here that doesn’t bode well for the science. It’s almost a case of "it does work"—the only question left to answer is how well it works.

When I ran black Scholes simulations, they were meaningless as the volatility measure was simply too subjective to make any true calculation meaningful. It's all about the results in Apr, that is the only volatility measurement that matters.