Elite Pharmaceuticals Inc (ELTP): SequestOx development is currently pause...

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Elite Pharmaceuticals Inc (ELTP)

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Tuesday, 07/12/2022 12:04:12 AM

Tuesday, July 12, 2022 12:04:12 AM

SequestOx development is currently paused yet Nasrat just asked the FDA and was approved for another filing fee waiver:

3 year gap and then asked them again.

2021 10-K
- "The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation to the original SequestOx™ studies and also extended our filing fee waiver until July 2020"

2022 10-K
- "The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation to the original SequestOx™ studies and also extended our filing fee waiver until July 2023"

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