Toxicity Study14 Oct 2024 19:40
Looking at the link that SoG posted on 12th October and having just re-read it along with other links, the prolonged toxicity study seems to be par for the course and would normally run parallel to Ph2 & Ph3 studies. I have no in-depth scientific knowledge but common sense suggests that this is a reasonable course of action with everything running in tandem during Ph2 and Ph3.
So the questions arising are: Why is Sareum conducting this study as a stand alone event? Why spend this money if we didn't have to at this stage? Why conduct the study upfront if Sareum weren't confident of the outcome?
My own speculative conclusion is that Sareum are stepping outside of conventional wisdom due to having a specific opportunity in the pharma world. I am not stating that a deal of any description is imminent but something is driving the need for upfront long term toxicity studies. Maybe Sareum see it as a cheap option over Ph2 costs that would enhance and maximise value. I do not think anything is wrong at all, nor do I think it is linked to MHRA issues previously. I agree with others here and wish for some form of clarification in the forthcoming Annual results and the forward looking statement. However, we cannot, and should not, expect the BoD to breach any form of NDA. It would be totally wrong to expect them to do so and nothing should be read into any lack of forthcoming clarity due to any constraints. We know where we are with 1801 development and we know the next steps. We also have it being developed now as "best in class". Nothing could be simpler.
Happy to be shot down by those with more knowledge of the Science but just putting some commercial logic out there.