this is the last post from me. But I dont like overstatements and hype to trick investors.
It has caught too many investors out. If you invest in a company do so from understanding the point of development and risk, which is what I was trying to do.
It is correct that getting an orphan indication is a good thing, but the FDA has not supported the drug and the clinical trial results (the product is not registered yet).
The stage of development is now at testing efficacy and because it has Orphan indication the bar is lower on burden of evidence than on other drugs (say for depression) because there is a need to get treatments for rare conditions and the capacity to recruit large trials is more difficult.
Still, I would have expected more given the hyped announcements. They dont match the evidence. I still think the company is in a good position to test out its drug and I hope for the community it works. If they do produce a trial like the TBI data though, on a couple of hundred patients, then no doubt there will be disappointment.
I think the peer-reviewersof the Pediatric Neurology article were generous. If it showed a good and reliable signal of benefit it would have been published in New England Journal of Medicine (Impact Factor = 72; Like a recent cannabodiol study of similar size for child seizures which while not conclusive provided a nice signal).
I just wanted to know if there was anything else to warrant the hype.
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this is the last post from me. But I dont like overstatements...
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