Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Name a few...

Yes, trials & studies have halted many times due to positive results known well in advance of planned end date as great benefit to patients.

This represents a fundamental misunderstanding of how clinical trials are designed. The number of subjects is calculated ahead of the study to be sure it is adequately powered. Too few participants increases the likelihood of either missing a positive effect or detecting a false positive. The result is not "significant" until it is seen in a minimum n number of participants. Terminating a study early would mean never achieving n and therefore never achieving statistical significance. STEADY-PD-III study was specifically designed to be a long and large study. Either decreasing the n or decreasing the t would be to degrade the study quality post hoc, which is silly and would never happen. The suggestion that since the study was not halted the results must not be significant is unscientific and flat out wrong.



FDA halts studies all the time because of safety concerns. They very rarely halt a study early because of positive effects. If it has happened "many times," as you say, then please give a few examples in the past few years. Take a look at Contrave. The CEO touted the CV risk reduction based on early results. As the study progressed and n increased, the effect was no longer statistically significant. The CCF researchers and the FDA were very pissed about the early release of data. The study was eventually invalidated as a result, and millions of dollars were flushed down the toilet.