Replies to post #261319 on Elite Pharmaceuticals Inc (ELTP)

[Padin]

In my opinion its not a race to be the first.. the market is so big even capturing a small %, still makes big inpact on ELTPs revenues

[pte]

Would someone who is knowledgeable in labeling answer freegriff's question.

"Serious question. I was reading over EGLT, a competitor who has an upcoming IR ADT PDUFA.

As you all might recall, theire ER ADT only got a single ADT label, not the trifecta. I read the following "The good news: the company received approval in Jan. 2017 and will be selling ARYMO ER in 2Q17; the unexpected bad news: the FDA permitted the label to state that ARYMO was an AD product by the intravenous route of abuse, but not oral or nasal routes of abuse, because a competing product (MorphaBond by privately-held Inspirion Delivery Sciences) was granted a three-year label exclusivity for the other routes of abuse when it was approved in October 2015." from Bret Jensen.

The question is, are we in danger, if SequestOX does not reach labeling first, at missing out on the labeling if we are not first? "

[WeeZuhl]

The question is, are we in danger, if SequestOX does not reach labeling first, at missing out on the labeling if we are not first?

While there is legislation in Congress regarding ADF labeling, under the current protocol, there would be no effect on SequestOx unless a prior drug was approved that is 1) A capsule *AND* 2) combination of oxycodone and naltrexone.


For example, Roxybond's approval as IR oxycodone has no effect on SequestOx because it is a tablet and single-entity oxycodone.