Replies to post #302175 on Elite Pharmaceuticals Inc (ELTP)

[Chasing]

We need more specifics to know if it's apples to apples comparison. There have been many many trials with positive results. I would say that at least 99% were not stopped prematurely. If true, one can't accurately say "if results were significant, the study would have been halted". The odds and percentages would say otherwise. One could say the study may be been halted but not assert it as if it's an absolute.

[NASDAQ2020]

They would if everyone ones was cured. That’s not what this study is all about.
This trial requires completion to determine if symptoms of Parkinson’s have been reduced and if so exactly how much.
So don’t expect it to be halted.

Locked & Loaded

[Jimmy Joe]

Well I can think of one such study that had great results but was stopped prematurely. Vioxx.

Long term studies not done. They botched that one.

[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.