GREY:ATBPF - Post by User
Post by
Pragmatiston Apr 27, 2020 1:34am
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Post# 30956227
Will Trial Results Be Sufficiently Conclusive?
Will Trial Results Be Sufficiently Conclusive?I am concerned that Antibe’s trial results will be inconclusive. Results from previous trials have not demonstrated with any degree of certainty that ATE 346 will achieve comparable pain relief with higher doses of Naproxen. There are some strong indicators, but do these provide sufficient proof? Also, the earlier phase 2 trial showed significant reductions in adverse gastrointestinal effects. But were these due mainly to the H2S additive, or more due to the much lower Naproxen content in the drug? One would expect that the adverse effects of Naproxen would increase in a non-linear relation with dosage. Why did the trial compare ATE 346 250 mg with the prescription dosage of Naproxen, and not the much lower over-the-counter maximum dosage ( max 440 mg per day for pers over 65, the age group most likely to suffer from osteoarthritis). Would 440 mg per day Naproxen produce similar results as ATE 346?
I am concerned that the results will be inconclusive because of the subjective nature of the WOMAC scoring system. Also, the variance in the amounts of ATB 346 Naproxen being investigated in the efficacy study are quite low. Will 150 mg of Naproxen produce a significant change in WOMAC scoring than 200mg? Will pain relief with 200mg be significantly different with that of 250mg? How much will the “placebo effect” come into play? Will these small variances in dosage, combined with the varying degrees of osteoarthritis pain suffered by trial participants produce inconsistent results? How would inconsistent results affect share price? (check out ACASTI Pharmaceuticals!)
Worst case results from the trial: No statistical differences in the WOMAC scores and the various dosages/placebo. Slightly better case, some positive but inconsistent results. Best case, results as hoped for, all shareholders get rich, and the world is in a much better place.
I suspect that there are a lot of anxious shareholders with their fingers on the sell button. I wish you all the best and hope the soon to be released news is extremely positive