Xartemis XR FDA Approval

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Why does everyone think the PDUFA date has passed? A three month extension was announced in November. The original 6 month approval time thus became 9 months, putting the PDUFA date in late April, 9 months after submission.
 












It will be a challenge without the deterrence endorsement from the FDA. The greater obstacle will be the local and national formulary coverage. Just bring it on and let's get after it.

The waiting is the hardest part.
 


















We will, obviously, hear something definitive soon. You know, with the launch meeting a week away and all.
For all of you who have been around for a while, this is SOP with the FDA. No way this drug will not be approved. it's SO good, the FDA is struggling with giving an indication and wording that might be seen as an.. endorsement.
 




































Anonymous said:
Interesting to observe the market reaction to the approval without the deterrence language from the FDA.

MNK is down 3% through mid-day EST.
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Your point?
Listen, if you can't sell this drug without an 'endorsement' from the FDA, which will never happen for ANY opioid, then you are not good at this… or you don't understand the pain market.
 






Anonymous said:
Your point?
Listen, if you can't sell this drug without an 'endorsement' from the FDA, which will never happen for ANY opioid, then you are not good at this… or you don't understand the pain market.
Click to expand...

So you are saying that Mallinckrodt doesn't understand the pain market for seeking a deterrence label from the FDA.

You've got your head up your ass if you don't understand that deterrence labeling is a must for next generation opioid pain meds. Have you missed the Zohydro backlash with the FDA coming under fire for approving this ripe for diversion and abuse drug?

My point is that a new drug approval usually translates into a bump in the stock price and that hasn't happened with XXR. Those that know the pain market understand that without deterrence labeling, XXR will have an uphill battle gaining traction against lower priced generic competition.
 






Exactly. Trouble gaining traction, but not impossible. Surgeons writing for less than one month aren't going to be worried about tamper resistance.

Why didn't we get tamper resistance? The pill has the same qualities as OC. I don't get it. Is. Mallinckrodt going to pursue the indication?
 






Anonymous said:
So you are saying that Mallinckrodt doesn't understand the pain market for seeking a deterrence label from the FDA.

You've got your head up your ass if you don't understand that deterrence labeling is a must for next generation opioid pain meds. Have you missed the Zohydro backlash with the FDA coming under fire for approving this ripe for diversion and abuse drug?

My point is that a new drug approval usually translates into a bump in the stock price and that hasn't happened with XXR. Those that know the pain market understand that without deterrence labeling, XXR will have an uphill battle gaining traction against lower priced generic competition.
Click to expand...

Son, I haven't missed anything. This whole job is an uphill battle and you're either up for it or you aren't. I suspect you aren't, from the tone of your post.
Of course such labeling would be desirable. It just isn't going to happen in the way you want, and it isn't a "MUST".
Explain how it is "ripe" for abuse. I think it's actually 'rotten'. As for diversion, how could any technology affect that? Or any labeling? Do you even understand what diversion is? Or are you just throwing words around?
 






Full disclosure: I am an internet troll looking to obtain competitive information on XARTEMIS XL. I will use this information for nefarious ends that benefit me and me only.

How is this product doing? I've been trying to find sales data but it's one big black hole, which probably answers my question already.

Thank you for advancing my career to the detriment of yours.
 












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