Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Not sure what you mean.

They may have done us a favor by not challenging prior to the CRL. If we needed to wait 30 months only to get a CRL it might have cost us another year and a half.

When you say "30 months", what are you referring to? If it is the FDA's automatic 30 month stay that occurs when one company sues another for patent infringement, I don't think that is applicable here. When the SequestOx NDA was filed, the RLD's were Roxicodone (oxy) and Revia (naltrexone), so Elite would have to certify that none of those patents are infringed and would send Paragraph IV notice to Mallinckrodt and Teva within 20 days, and then those companies would have 45 days to file suit. Then is when an automatic 30 month stay would be put in place. That did not happen. However, if Purdue or Pfizer believe their patents are infringed for antagonist ADF tech, then the suit would come later, likely on approval (why sue early and get in the way of Elite tripping over its own 2 feet?). Then it would be up to a judge whether or not to grant a stay depending on the merits, nothing would be automatic. Also, tentative approval could be given during the stay, assuming it is bioequivalent and deserves approval. If there was a stay, it would not have delayed a CRL or tentative approval- only the final approval.