You generally find Hotcopper posters are either enthusiastic or analytical... rarely both.
Safety/toxicity studies are in progress for both neurology and ophthalmology. Once results are in, and we feel very confident that the results will be positive based on the relevant factors, we expect a moderate re-rate in the share price and phase 1 trials can begin.
The relevant factors we feel support optimism for the safety studies are:
- In vitro studies have been positive at multiples of the planned dosages.
- EmtinB is a naturally occurring protein in humans so we are expecting little or no effects outside the systems where this protein is active already.
A highly positive finding for Glaucoma (opthalmology) is that when the treatment is applied as eye drops it will still reach the interior of the eye in effective concentrations. So while the studies will proceed using the traditional delivery method of intraocular injections, there is a massive potential benefit in terms of market size and global delivery in pursuing the eye drop option.
With respect to trial results you will typically find that the reliability of the result is shown as either a p number or a confidence interval (CI).
- The p numbers is the probability that the observed difference (e.g. 45% improvement) is the result of random selection rather than a real different. A result with p=0.01 translates to a 1% probability of the result being a random outcome. Smaller p numbers are better.
- Confidence intervals specify a confidence value (e.g. 95%) and a range of outcome values (e.g. 37%-54%). So results might say "increased axonal regeneration 119% (CI95%: 93%-137% )" [note, I made these numbers up]. This means that we observed and increase of 119% in our sample and can be 95% confident that the "true number (for the entire population)" is between 93% and 137%. Narrower confidence intervals are better.
There are other measures of significance and confidence, but we are not likely to see these used in studies measuring continuous numbers like growth rates, survival times, lengths, thicknesses, etc.
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