Elite Pharmaceuticals Inc (ELTP)

[guti]

The Epic Pharma facility has nothing to do with the matter any longer, ever since the acquisition by Humanwell Healthcare Group and PuraCap Pharmaceutical on March 31. On March 17 the FDA had agreed to go into a more detail review with a PDUFA date set for SequestOx and due to the timing of the acquisition, the required changes for manufacturing/marketing sites where probably not made. In addition, PuraCap International was created on March 24, when PuraCap Pharmaceutical acquired two other companies, Blu Pharmaceutical and Blu Caribe which open their market to include oral tablet and capsule dosage forms for both the U.S. and global markets. So there where a lot of changes that took place after the FDA had agreed to the review. In a few minutes we will find out if any of that is what prevented the approval at this time, or if it was labeling. It would be better than a problem with the study.