Elite Pharmaceuticals Inc (ELTP): why wasn't it identified and fixed prior...

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Elite Pharmaceuticals Inc (ELTP)

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Re: vanwes1 post# 258433

Friday, 05/26/2017 1:11:31 PM

Friday, May 26, 2017 1:11:31 PM

why wasn't it identified and fixed prior to the first submission for approval.

We've been over this ad nauseam. There was no need to "fix" it, as you say. According to the FDA, it didn't need a fix, just some labeling. If it aint broke, don't fix it. It's the FDA responsibility to say if it's need to be fixed; they didn't.

The spin just keeps coming.

You can believe it or not; I don't care.

If you cant enroll patients then the trial cant meet the primary endpoint. If you cant stay in the trial because you are disqualified then you cant be included in the final analysis. Does anyone see a problem with this?

Yeah, I see a problem. Stating the problem would get my post deleted, though.

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