InvestorsHub Logo

sharkey1

07/03/23 8:26 AM

#382058 RE: jour_trader #382057

Yep, you are absolutely correct.
In addition, the company submitted partial ANDA for pain management for review by FDA. The partial application contains the recently conducted insufflation study. Elite intends to provide the FDA with the remaining data in Q3 of 2023 to complete this filing. We disclosed a while back that we're actually continued working on a generic version of Oxycodone. And the last time we filed it, we had deficiencies and one of the deficiencies that everybody got is that an insufflation study was not conducted. It was cost prohibitive. That study alone is about $1.5 million, $2 million, and this is why we put the project on hold.

you just keep believing that.
Bullish
Bullish

jour_trader

07/03/23 8:45 AM

#382059 RE: jour_trader #382057

Go back and read other cc’s on this. He has stated multiple times how there are others. Just don’t expect them to be the first. I’m hoping the ANDA is approved by end of next year, but won’t be the first. It’s a big pie and Elite has proving flexibility now with their own sales & distribution channel. Let’s see whether Elite can build out a profitable strategy. That is the question Nasrat is still concerned about as stated in the recent cc.

JamesF1

07/03/23 9:11 AM

#382061 RE: jour_trader #382057

Regarding OxyContin, Intas challenged the Purdue patent and won. They will be first to market. If Elite gets approved second or tied for second with others, that would be a major positive.