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Pharma Sleuth

09/26/23 10:57 AM

#388398 RE: WeeZuhl #388396

Interesting take. I dont discount it. You might be on to something. this is an old product though already with approval that they sold? no?
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JamesF1

09/26/23 11:23 AM

#388400 RE: WeeZuhl #388396

FWIW, I think yesterday was about Oxycontin. Since Elite sold the Norco ANDA's to Nostrum, my GUESS is there would be a non-compete included in the sale contract. Another quick comment: Norco is hydrocodone +325mg Acetaminophen. There is also hydrocodone +300mg acetaminophen on the market (generic Vicodin). Medically there is no difference, but oddly the combo with 300mg acetaminophen is a bit more expensive. It would be a different ANDA filing. I still think the product is Oxycontin... we will find out next year (I am not venturing a guess on when in 2024... I don't know). Good Luck to all.
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jour_trader

09/26/23 11:30 AM

#388401 RE: WeeZuhl #388396

Here is wording from Q4 cc on PDUFA date that kicked off for Oxy at time of partial filing or we are so led to believe:

“Once we did the insufflation study, we are resourced because the results were positive and we wanted to make an announcement. But then we learned that there are three other companies that are doing the same thing and we did not want them to beat us to the punch by knowing that we just made an announcement that we're going to file. So we had to be quiet, wait till we file a partial application to get the PDUFA date going, okay? And now I can tell you about it. The full application should be filed by August 1st and hopefully the FDA would accept it. That usually takes 45 to 60 days and once they do, we'll make an announcement. “
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The ELTP King

10/01/23 1:29 AM

#388597 RE: WeeZuhl #388396

ATTENTION Walmart shoppers!

We have a RETARD on isle 7.

I REPEAT, we have a RETARD on isle 7.

If the OxyContin PDUFA started in Spring (maybe it did!), then yesterday's PR was about something else. You can't have it both ways. The PDUFA date is set when the application is accepted by the FDA. To claim the PDUFA date was set in Spring is also claiming the application was accepted in Spring. That's just how it works. If OxyContin was accepted in Spring then something else was accepted in September. What do you think it is?