No question that the recruitment has been much slower than anticipated.
" We expect to complete patient recruitment in the Phase 3 clinical trials by mid-2023, with topline data to be reported when all patients complete the 52-week treatment period for the primary analysis"
So topline trial results would be available perhaps by late 2024?
Currently expenses seem to be running around $60m pa.
With $88m in the bank and some tax relief that gives at most 18 months of funding which won't be enough to complete the trial. So they will have to raise further funding and I guess the recent announcement provides a pathway to issue further equity.
It might still be possible to make up lost time as Covid restrictions resolve.
"Opthea is now actively recruiting patients for participation in the Phase 3 program from all major geographical regions around the world. Our first sites to open were in the US and within months we reported the initiation of patient recruitment in Canada (August 2021), Europe (October 2021) and Asia-Pacific (October 2021). When fully activated, we expect over 200 clinical trial sites to participate in each of the ShORe and COAST studies respectively. "
Very disappointing progress. It was always going to be a simple gamble on the outcome of the trials with the hope of a licensing deal even before the results are announced. On the other hand, if both trials fail the outlook will be grim. If they are successful however then
"If the topline results at the completion of the primary efficacy phase are favorable, we intend to file for marketing
approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other territories. "
If interest in the stock is only likely to come in the six months before the results, I guess it will drift for the next two years...
I had hoped for better but this pandemic has screwed everything up for everyone in the world. Unfortunately it is not worth pointing the finger of blame at the people responsible for letting the virus out and those dealing with it in an unscientific manner.
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