I have been re-reading larry glass's TBI conference slides from 2012 and its hard not to be cautiously optimistic about this upcoming trial. As I keep telling my mate, its a 103% chance of success... but you never know in a trial.
The preclinical data shown is pretty compelling, to me in particular the apparent dose dependent reduction in GFAP (brain injury biomarker), reduction infarct size (literally dead tissue area), reduction in neurological impairment and reduction in seizures. Given the correlation between pre-clinical data in retts/fx and a positive result we would have to be an above average chance of a win on this upcoming trial also.
Now I know they are completely different - chronic genetic vs acute however it is more the proof of concept in animals/preclinical translating through to positive trial results that gives me the optimism.
Surely (famous last words) if it is reducing that acute inflammatory response so markedly in the initial stage of a brain injury, that will result in a positive outcome.
The big if is - as stated in this presentation - the placebo response is very high. Im hoping clever trial design (which is a common theme for the previous 2 trials) will get us around that.
Not long now to wait although it feels like an eternity at the moment. very exciting times if it gets up and would go as far as saying strong results in this trial (plus the retts/fx trials) would be one of the biggest breakthroughs (IMO) in recent times .... which will attract a ridiculous price tag.
As other posters have mentioned, even without TBI , Retts and Fx is extremely valuable to big pharma even if the market doesn't agree at the moment.
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