Xartemis XR FDA Approval

Old news. I'd love to hear something new… and positive. I really want to sell this, but with all the insanity going on in our Nation's Capitol, WTFK?

 

Crickets......

 

What happens if it is not approved?? We know the ventiv people will be immediately overboarded!! But what about us?e

 

Incorrect all FDA headquarters and buildings are open and operational including the white oaks facility.

 

We aren't the only ones waiting to hear something. Other companies are in the same boat. No news isn't necessarily bad news. Hang in there everybody!

 

For the first wave of Ventiv hires on this contract, employment was contingent on XXR FDA approval by March 5th. No approval yet so now what happens?

 

I am hoping for the best but preparing for the worst. Now is the time to have you and any insured dependants get their eye exams and glasses, get dental exams and any repairs made, punch out any medical exams, tests, lab work, get 90 day prescriptions filled, load up on office supplies and submit expense reports on a timely basis. This contract could be shut down at any time and you should exercise your benefits while you still have them.

This contract may turn out to be a classic example of why pharmaceutical companies should never hire and train a sales force until a drug is formally approved and the launch is ensured.Prepare yourself for any eventuality. This is a relatively small spinoff startup and the branded division is a one trick pony in the near term. With Exalgo soon to go generic, there simply is not enough Pennsaid business to justify the currently sized sales force if Xartemis XR gets shot down. You need a huge tolerance level for ambiguity, uncertainty and vagueness in order to hang with this contract. I hope it pans out for everybody with a stake in it. Good luck!

 

Mallinckrodt has hedged their bets on Xartemis with the ability to pull the plug on a contract sales force, providing temporary rented fleet vehicles and not providing company issued credit cards to the Ventiv employees.

They've dodged hefty U.S. corporate taxes with the shell of a headquarters in Ireland and stand to build on this success once Cadence is rolled under the corporate umbrella. This is a slippery start up operation that to date, has managed an amazing run up in the stock price but could face a precipitous plunge if XXR is not approved.

Stay tuned...

 

Are we ever going to hear ANYTHING?

What seems strange to me, is that when looking at the FDA calendar or investment calendars for upcoming products, there is no mention of MNK or Xartemis XR. They don't show the PDUFA date of FEb 28 that we are all thinking about.

 

Small-cap pharma companies are always a house of cards waiting to fall. Their success is usually tied to one or two drugs that must survive the FDA gauntlet to make it to market. Then if it beats the long odds and its drugs are approved, the company appears on the radar of big pharma that is always on the prowl for an acquisition to staunch their flow of declining earnings in this era of the patent cliff and r&d failures. The only winners in the long run are the corporate officers that can hit the jackpot with their stock holdings and options to cash in once a buyout occurs. Just ask the upper mgmt of Cadence. Any big pharma company with a pain portfolio like Pfizer, is always scanning the horizon for another bolt on acquisition that dovetails with their current brand lineup. Make the most of the current opportunity, build your resume and save prudently.

 

Action timelines:
If no approval by this weekend, the NDA is in trouble.
If the NSM is still a go, a definitive answer must come down before the end of March or the Ventiv contract will either be yanked or reps furloughed.
If deterrence language is the only sticking point, they may have to launch without it initially and continue pressing for it. May have to spin abuse deterrence inferences as with Exalgo.

 

This NDA has been in trouble since the Priority Review period was extended.
A transparent company doesn't conduct a Town Hall Meeting and not take questions. They are in a damage control mode and have painted themselves into a corner. They can tell us it's not productive to speculate but hiring and training a 150 person sales force without a product approval in hand is the epitome of speculation.
FDA approvals typically are announced after the markets close late Friday. If it doesn't get called one way or another tomorrow, we will likely be SOL.
If Ventiv has any ethics, they will make it a priority to place Mallinckrodt contract reps on another contract ASAP if this one gets pulled.

 

From the negative chatter here, it sounds like the contract pawns are going rogue.

 

Just a weather delay?
Sounds like a snow job to me!

 

Despite the approval delay, the stock price just broke the $70.00 mark this morning.

 

That sounds positive. Those guys are close to real sources, more so than some of the negative commenters here. I wash they'd say something to us, other than 'just stick to the plan'… I have heard that song before. A couple of times.

 

According to the March4th FDA approval list, it did make that list.

 

More bad info. Not on list.

 

Mallinckrodt is not the usual small pharma. We are not attractive because of the API, generics and nuclear/diagnostic divisions. Not that a Pfizer couldn't acquire us, but Mall is not attractive because you just can't come take over or buy the branded division. What makes us unattractive to buyers make the company stronger to stand alone.

Relax people. This drug will be approved soon, with or without abuse resistance labeling.

 

Covidien/Mallinckrodt has been around for awhile and they just shed all their liability when they spun off of the device side. If Xartemis is delayed again for one reason or an other the company isn't going to fold. They will buy or acquire a product or two to bridge the gap between product approvals. Xartemis will get approved the question is when. Plus an even bigger money maker in the pipeline right around the corner. These message boards are always filled with pessimists that constantly complain and look at the glass half empty. They're the reps that leave and go somewhere and bitch after the honeymoon period is over at their new company.