The CEO is very openly bullish and since she is a lead researcher of the compound she has some credibility. In the past it has not been wise for a CEO to speak so openly about anecdotal responses but in this market place with such financial pressure by shorters there needs to be some tools or tactics for CEO's to use to support a fair valuation of their shares.
This is a fascinating compound, from its design to its MOA to its recent P2 data, though limited in volume. I place some weight on the 54 PD patients data since it is a reasonable mid size sample size to attain a starting point for stats. I don't think I have ever seen such a strong stat performance from such a small sample population, which is eye opening. The observations of rapid enrollment and low drop out rates in both trials are indicative of trial physician support and at least patient safety success.
The contradiction here is that the MOA is superbly simplistic and holistic as far as neurodegeneration is concerned but the logic of its approach gives one the initial impression that there is no way Big Pharma could have missed this approach. But BP can be blinded at times and it takes years to decades to modify their approach. This approach seems too simple, but this would not be the first such example of a simpler approach being correct since the scientific achievement is in finding how to make the simpler approach a reality. This compound's MOA helps to explain why there have been other single degenerative protein approaches which have demonstrated limited temporary success only to completely succumb in the longer term as only one degenerative protein is being controlled by the other compounds while the other degenerative proteins continue to agglomerate in the brain. This means there exists synergy between the decades long BP approaches and this one.
The alignment of all the preclinical through early to mid clinical data is consistent but in the field of neuro there are hurdles of proof in cognitive testing, which is why Parkinsons mobility is a great complement to evaluate concurrently with AD cognition. I see this as an interesting SWAG at this stage as there is compelling data but not a lot of it, otherwise the company would already be in the billions. Not many small companies, though I know of one in oncology, can offer such potential value. This compound, like the other company I reference could bring medical science revolution to the market. The benefit this company has is a shorter development timeline than the other company, more traditional trial metrics, and it has not garnered the destructive attention of large shorting entities. The timeline here now does not allow for large shorting games and the potential upside value is too significant of a risk given the low float.
All in all this is still a binary investment situation but there is a strong positive case for a potentially successful outcome in a medical field where all have failed to date, except a few very limited successes. Patenting the newly developed crystalline form of the compound for IP purposes in addition to added stability is a positive. I think, given the safety profile that will be available and the proof of the MOA post both the PD and AD trials in coming months if both trials are successful, the FDA will be receptive to an accelerated approval pathway, at least that would be logical and patient serving though it is possible there may be additional P3's in both indications required, strength of results may be the determining factor.
GLTA
