Agree. I would start with the KOL's and Megan, if I had some serious concerns.
It's great to have independent thought, if capable, on this issue. However, a strong reference point for me is what has the smart money been doing. By smart, I mean in-house medical/bio/valuation expertise. In this case, we have Regal who have two medical professionals on board who are focused entirely on understanding the issues and asking the right questions to KOL's and Megan, if they have queries. You also have a specialist Bio Fund on the register. Both these groups not only have capability to understand the bio/regulatory/clinical trials issues and spend whatever it takes speaking to the right people, but then have the other skills in-house to value the business through their analysts. Now, both these funds made a significant profit on the results of the recent trial. So what was their response? Take some profit off the table, sell out to retail chumps? No, they paid up big time to increase their holdings significantly. Note, these funds were fully up on the science and expectations from the trials as they had been holding for a number of years and sweating on the trial data. I would completely differentiate these fund's high conviction actions to a number of research analysts who have put some decent price targets on OPT. BIG difference between skin in the game and free shot at being a hero by making 'speccy' call.
This hasn't stopped me from trying to understand what could go wrong from here, as the upside will take care of itself. I have a regulatory affairs background and have made trial submissions to the FDA for device approvals. In this respect, if they can replicate their 2B trial results, there won't be any issues. What could go wrong? Various things, but none to me would be deal breakers, as they have shown OPT-302 is significantly more effective than current SOR for the portion on Wet AMD patient population whose lesion type is not predominately classic. What I am trying to find out is, was the study a true statistical representation of lesion types i.e. only 12.6% (i.e. 15/119) of all Wet AMD patients are predominately classic? At least it's great to know this difference in effectiveness before designing Phase 3 trials. The only other slight concern I had was the drop off in BCVA at the end of the trial for OPT-302. A longer follow up in Phase 3 may show something unexpected. However, this is less of a concern now that I can see the break up in patient types. Both treatments had a drop off for Minimally classic (though slight sharper drop for OPT-302) and the Occult group did not show a drop off. I would be happy for anyone to point out any other key risks for Phase 3 trials. Otherwise for me, the strength of the statistical significance of outperformance despite the over performance of the control arm, provides a very good buffer for Phase 3 trials. This is what minimizes the chance of a complete blow out and valuation wipe out when Phase 3 trial results are announced.
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