What a confusing day it was for everyone yesterday.
Within the study was stellar clinical trial results for people who have non reticular pseudodrusen (RPD) intermediate age related macular degeneration (iAMD) . The effect size was impressive. According to slide 13 of the investor presentation released at 830 yesterday approximately 7% of the 2RT treatment group compared to 20% of the sham-treated controls progressed to late stage AMD. I agree with the statement that the "result is highly clinically meaningful and showed a remarkable treatment effect" (slide 15 of the same presentation). The results were certainly worthy of publication in Opthalmology - one of the top peer reviewed journals in the field.
However, confusing the situation was the fact that those with RPD had a much faster progression to later stage AMD. I disagree with comments inferring this significantly impairs the progression of 2RT. It is not uncommon for a treatment not to work in everyone. For example, ACE inhibitors are a clearly proven oral medication for hypertension. However, they will significantly worsen outcomes if they are given to patients with severe aortic stenosis (a heart valve condition) or advanced kidney failure. To me the results of the study by Ellex just gives a clearer indication of the target group that will benefit treat (those without RPD).
Thanks for the comments from "TitusPullo" yesterday on Hotcopper. He clarified the newly developed FDA process for the accelerated approval of new treatments. It looks like Ellex will have a good shot at getting early permission. They could perhaps market 2RT while performing another RCT and/or have increased post-marketing surveillance. In the meantime I predict there will be a considerable increased in sales of 2RT in the Eurozone and other areas where 2RT can be sold. It is important to remember that billions of dollars annually are spent on treatment for advanced AMD to reduce the risk of blindness. Given this it is not unreasonable to think that the treatment for iAMD could be a market eventually worth billions annually.
I agree that the trial result was confusing and that explained the market volatility yesterday. However, I'm confident that with time the real value of the clinical trial will be recognised. There will be interest in the results at the Euretina conference this weekend and increased analysis and recognition of the findings by medical professionals, the media and stock brokers over the next week. This will lead to a re-rating of Ellex. Until thevalue of this finding is realised in the share price of Ellex it definitely remains a takeover target.
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- Ann: ELX LEAD Clinical trial results
Ann: ELX LEAD Clinical trial results, page-41
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