Replies to post #203334 on Elite Pharmaceuticals Inc (ELTP)

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Depending on the FDA for duration and N. Pfizer last P3 took N=280. The FDA will need to decide what type of Pain Trial is required.

Moderate to Severe Chronic Low Back Pain is the worse of the worse criteria. Drug: ALO-02 vs Drug: Placebo

Enrollment: 280
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

3 years later 6/7/2016 something very weird going on that the FDA has delayed any approval for ALO-02

There is a chance that at the Pre-meeting this morning that Pfizer may convince the ADCOM experts that it would take considerable sophistication to defeat ALO-02 with M27.

Since $ELTP Pivotal Bioequivalence has been listed early this year most likely IMO that $ELTP has already made decisions for ELI-201 and ELI-202 ADFs

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31 Phase3 Bunionectomy Clinical Trials, Some with ER.

https://clinicaltrials.gov/ct2/results?term=Bunionectomy+and+Phase3&Search=Search