The last investor presentation announcement indicated:
- Trial approvals expected to come through on a rolling basis depending on ethics and reg approval requirements of the individual authorities
- "Clinical trial agreements being executed with all trial sites and submission of the clinical trial application to be made to each of the national regulatory authorities
So the clinical trial applications had not been submitted as of the end of May. I'm not sure we will see another announcement regarding this until we actually get some approvals back from each country (wish they listed what countries the trials would be in).
Another part of the announcement stated:
"Trial approvals to come through on a rolling basis depending on ethics and reg approval requirements of individual authorities"
Lets assume the following for a best case analysis:
- All clinical trial applications have been submitted
- All applications are complete and will not require resubmittal
- The 9 countries that the trials will be held in are: UK and other EU countries (grouped because same clinical trial application process)
Here are the timelines for clinical trial application reviews (I wasn't clear whether UK is under the same EU process, so have assumed it is different but this may be incorrect):
- UK (30 Days)
- Other EU countries will be on the below timeline, which is founded on the Clinical Trials Regulation (CTR) reform that came into place at the start of 2022
So based on the below timeline, even if all clinical trial applications were made during the time period between the investor presentation and now, we would still likely be looking at 60 days for approvals in the best case.
I don't see the end of June dosing as being possible. I will reach out and see if the company can confirm if any applications have actually been submitted.
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