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opt shareholders deserve a conference call, page-19

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primaus72

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24/04/25

18:30

Post #: 78796978
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Originally posted by Cornhulio: ↑

Just spit balling here

Maybe the FDA hold a pathway out of this ClusterF for OPT and the DFA Investors.

The FDA having previously review the data of both Aflibercept and Ranibizumab during the approval of these drugs and FDA would know as well as anyone what is to be expected from these drugs. The FDA would be as interested (as OPT) to understand the anomaly in the performance of the comparator arm as reported in both the COAST and ShORe trials.

Sozinibercept in ph1 showed safety and efficacy as a monotherapy (there maybe a monotherapy approach there), in the ph2 trail safety and efficacy of Sozinibercept in combo is well documented.

OPT could approach the FDA asking to be granted an Registrational Study Pathway (as displayed in the second diagram) to market Sozinibercept in combo whilst undertaking further confirmatory studies post marketing surveillance (phase IV) to address what appears to be an anomaly in the comparator arm.

Sozinibercept has a strong safety profile so allowing Ophthalmologists to prescribe Sozinibercept to patients who have had a poor response to the SoC won't be an issue it either helps or it doesn't, based on the real world feedback of Ophthalmologists & KOLs over a defined period the FDA could either confirm the Marketing Authorization or withdraw it.

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FDA fast tracked this drug because the current SOC was lacking hence to find SOC suddenly provides 14+ letters means a huge anormaly - basically the trial was stuffed and OPT mgt is doing some ass covering to avoid getting sued is probably what is happening behind the scenes.

OPT Price at posting: 60.0¢ Sentiment: Hold Disclosure: Held
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