Good morning Mason,
Thank you for your comments and input. It's always good to have a balanced discussion on these things. Especially if we have hard earned invested (I've only got a little at the moment)... And I'll add, it's very valuable having comments with someone of your knowledge and experience in the field.
In relation to your first point. I also have thoughts around this. I'd like to know the BMI of the patients over the time and if the ones with the best outcomes were also the ones where the drug assisted them with weight loss. I often challenge these types of results and ask if the outcome is causation or correlation so I'm looking forward to the detailed results that are expected to be published in a scientific journal this year... However, where I found comfort was in the 2.5hr results. Mainly because I had a family member who got bitten by a mozzie and eventually developed viral meningitis. She suffered from ICP pretty badly from this and the only medication prescribed were pain killers (her BMI would only be around 20 so that wasn't a cause). After finding IXC, I contacted my doctor who I discuss all my bio investments with (he's made good returns from it so always gives me plenty of time) and he also said that at this point in time the only drugs prescribed would be pain killers (panadol, ondansetron, etc) as well as anti-inflammatory diets. This made me think that IXC may actually be a suitable drug for these types of candidates (not just overweight women) that would benefit from the therapeutic benefit short term. However, for the purpose of proving efficacy they need the types of patients that are in this trial. Ie. it would be near impossible to complete a trial like they have with someone with meningitis...
In regards to the number of patients in the trial and the statistical significant results - this was also a concern of mine, in addition to how long the trial appeared to take (from what I could see it was from '15-'19), so before investing I contacted Tom Duthy to ask a few questions. In summary, he said that the reason for the length of trial was due to it initially being with Uni. Birmingham until IXC took over the IP and then included the real-time ICP measurements.
I questioned how they had a trial of 16, and now intend to do ~250 patients and how this will be possible. The response was that the reason why only 16 patients were enrolled for this trial was due to the real-time neurosurgery devices to measure ICP, and that it would be unethical to randomise a large number of patients to a neurosurgery procedure when there is a 50% chance they receive placebo. Also, by having the real-time devices it meant the results were more accurate and therefore a smaller sample size was adequate.
I imagine when they do complete the ph3 study they won't be using a real-time neurosurgery device due to the reason mentioned above and will therefore measure it differently over a longer period of time, and therefore will have a much larger sample size for significance.
IMO, DYOR, etc
