What's going on?

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anonymous said:
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141084.pdf

That's all.
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Yes all of those cases are with PSM and PSMX and even though they were done before Cytal was approved thats okay because the new indications make it so that the cases are not off label any more. Compliance has loosened up on these things which is a good thing for us. It all has to do with the DOJ investigation which is almost over. On the last region conference call our RM in the west said the DOJ investigation will be settled before the end of 2016 because he has the inside info from the new board now. Its all coming together now so stop overthinking about this they know what they're doing.
 






anonymous said:
Yep. Read pages 45,46, and 47 of the document you can find below:

http://law.justia.com/cases/delaware/court-of-chancery/2015/ca-10769-vcp.html
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Holy cow! This is funny you should read this. VP sales spied by listening through the wall. Sounds about right for him. Ignoble haha.

Page 46
" Defendants make much of the fact that (VP sales) acquired the information by eavesdropping through his office wall that he shared with (), the Company‟s General Counsel, on conversations of ACell‟s officers. That the source of the information admittedly was ignoble does not necessarily mean that, as Defendants contend, (new CEO)"s statement was “reckless[]”141 or “false and misleading.”142 "
 






anonymous said:
Yes all of those cases are with PSM and PSMX and even though they were done before Cytal was approved thats okay because the new indications make it so that the cases are not off label any more. Compliance has loosened up on these things which is a good thing for us. It all has to do with the DOJ investigation which is almost over. On the last region conference call our RM in the west said the DOJ investigation will be settled before the end of 2016 because he has the inside info from the new board now. Its all coming together now so stop overthinking about this they know what they're doing.
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What's the plan for settlement?
 






anonymous said:
Sorry, but you are mistaken. You might want to check the 510ks on FDA.gov
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Did you read this before you sent the link, its only 5 pages long. Page 3 is a pretty simple read, though maybe you misunderstood it. Ill try to help:

PSMX (6-layer)
PSM (3-layer)
...are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Thats the same indication as Cytal (basically for use in Surgical Wounds). Previously PSM and PSMX were not indicated for this use in plastic and recon. So, now that these are considered on label use, many of the old "off label" cases can be accurately promoted. The point was, the new brochure for Cytal shows PSMX product, not Cytal product. Both of which are acceptable, on label uses, but, it was comical that marketing used PSMX to promote Cytal.

Thats all.
 






Skittles said:
Did you read this before you sent the link, its only 5 pages long. Page 3 is a pretty simple read, though maybe you misunderstood it. Ill try to help:

PSMX (6-layer)
PSM (3-layer)
...are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Thats the same indication as Cytal (basically for use in Surgical Wounds). Previously PSM and PSMX were not indicated for this use in plastic and recon. So, now that these are considered on label use, many of the old "off label" cases can be accurately promoted. The point was, the new brochure for Cytal shows PSMX product, not Cytal product. Both of which are acceptable, on label uses, but, it was comical that marketing used PSMX to promote Cytal.

Thats all.
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I hope you are right, because the PSM and PSMX are still considered surgical mesh products, which is the reason for my concern.
 






anonymous said:
What's the plan for settlement?
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I'm not sure exactly he didn't give many details on the call because it was to the whole region but off the record I was told a settlement would probably involve a fine (about $10 million) and maybe a few more executives plus probably at least one RM would have to be let go due to the possession of off label sales documents that were used to train reps to sell off label using a personal email account. We won't know for sure until it's finalized but that is what the board is planning for. Business as usual for the reps so no need to worry about things just go out there and drum up business with confidence. Hang in there brighter days are ahead in the future for acell.
 






Skittles said:
Did you read this before you sent the link, its only 5 pages long. Page 3 is a pretty simple read, though maybe you misunderstood it. Ill try to help:

PSMX (6-layer)
PSM (3-layer)
...are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Thats the same indication as Cytal (basically for use in Surgical Wounds). Previously PSM and PSMX were not indicated for this use in plastic and recon. So, now that these are considered on label use, many of the old "off label" cases can be accurately promoted. The point was, the new brochure for Cytal shows PSMX product, not Cytal product. Both of which are acceptable, on label uses, but, it was comical that marketing used PSMX to promote Cytal.

Thats all.
Click to expand...

"comical that marketing used PSMX to promote Cytal." And that is a perfect example of how things are done at ACell. It feels like it is all going to come crashing down like a house of cards unless serious changes are made now. Yes the product really is great, that's why so many surgeons use it despite all of the problems with the company. But we all know at some point the science won't matter, the anecdotal outcomes won't matter, only quality clinical evidence will matter. Every day that goes by this becomes a bigger problem.
We don't need new/old products and a massive rebranding, we need evidence. In fact, I don't even want the attention the rebranding is going to bring, especially with a new more expensive product with no evidence to support it (or any of the other products they are already buying). None of the reps are excited about Cytal. But we are told we should be happy to sell a more expensive product because it means more commission, and the 'good' reps will be able to sell it.
Management and the board should be reading this blog instead of listening to the executives who don't understand the business, hide the sales numbers, suppress individuals, and lead through intimidation. They need to start supporting the sales reps and they should start by listening.
 












Beast Mode said:
New product launch with no new studies (technically there are no old studies either), no new "anecdotal" presentation cases (other than old cases that are NOW considered on label) and its MORE expensive (compared to the same product thats un-fenistrated)? Seems like a recipe for successful adventures in Value Analysis world.
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- In HIS words
The "good reps" will show the PSM/PSMX cases at the Value Analysis Meeting and they will sell the more expensive Cytal products and make more money. Because it is "the best." (No need to back up this claim, just quote me in bold with some exclamation points). The rest of the reps who are not the "good reps" are losers obviously. Somehow Acell has a knack for hiring losers every single year to replace the losers who failed already. It is the losers' fault for their failure. Acell will stick to this plan since it is working so well. Eventually there will be no more losers to hire. And the result will continue to be success like we had in 2015. Hence all of the promotions for in-house employees. Just don't count on that 401k match. It was the losers' fault.
 






Skittles said:
Did you read this before you sent the link, its only 5 pages long. Page 3 is a pretty simple read, though maybe you misunderstood it. Ill try to help:

PSMX (6-layer)
PSM (3-layer)
...are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Thats the same indication as Cytal (basically for use in Surgical Wounds). Previously PSM and PSMX were not indicated for this use in plastic and recon. So, now that these are considered on label use, many of the old "off label" cases can be accurately promoted. The point was, the new brochure for Cytal shows PSMX product, not Cytal product. Both of which are acceptable, on label uses, but, it was comical that marketing used PSMX to promote Cytal.

Thats all.
Click to expand...

Honestly, I don't see how these are wound care indications. If you look at Cytal's indications, they are for wound care.
 






anonymous said:
Honestly, I don't see how these are wound care indications. If you look at Cytal's indications, they are for wound care.
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You are right in that PSM & PSMX are not indicated for wounds. But read the IFUs for Cytal. There are instructions for fenestrated and non fenestrated Cytal. So Acell COULD make non fenestrated Cytal, which would be identical to PSM or PSMX. And there you have the circular logic. Cytal has never been used on a patient,
yet we have cases on a Cytal brochure showing what could have been Cytal even though it is actually PSM or PSMX. Now all is kosher, just in a convoluted way that the DOJ probably wouldn't be cool with. But what the heck, let's roll the dice. This is Acell.
 






anonymous said:
My vote is to save the million bucks they're going to spend on the NSM and put it into a study. The whole NSM is going to be compliance and regulatory threat sessions.
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We don't need studies. My studies are on my iPad. I am vps. I've closed millions of cases. I show mortar man and surgeons are amazed. Compliance won't stop me from showing that case, I saved it on my iPad. I'm so clever. Hahahahaha.
And spending money on studies would be giving in. You are missing the point which is this: We don't need studies, WE HAVE THE BEST PRODUCT! Why don't you just say that? I did, read your emails.
Why waste money on a study when I can just tell the reps how bad they are at their jobs? Doing that results in results, and I'm a results kind of guy. Unless I don't like you. Or unless my results are bad, then it is someone else's fault. The only reason sales stopped growing and turnover is awful is because the sales reps are no good, it has nothing to do with strategic decisions or lousy sales leadership and lack of sales training. I will explain in detail why this isn't my fault, I have a lot of excuses for my own results. Look, all you have to do is ask your manager how I did it and then follow the blueprint. I've sold millions of anastomosisoses and that has saved lives. It's not that hard once you figure it out. CRACK OPEN THE SAFE. And if you need help the regional managers are really well qualified and knowledgeable. THAT'S WHY I HIRED THEM. All you have to do is ask. You know what? You are a complainer. If you can't do it I'll find someone else who can.
 






This discussion reminds me of a great Limerick I heard once:

There once was a man from Nantucket,
ACeLL management sucks.

Wait, I'll try it again,

There once was a man from Texas,
He drove a Ford not a Lexus.
He woke up one time,
Quoted himself in a rhyme,
And then he moved back to Texas!
 






anonymous said:
This discussion reminds me of a great Limerick I heard once:

There once was a man from Nantucket,
ACeLL management sucks.

Wait, I'll try it again,

There once was a man from Texas,
He drove a Ford not a Lexus.
He woke up one time,
Quoted himself in a rhyme,
And then he moved back to Texas!
Click to expand...

Wait, he moved back to Texas? Do you think he got the hint?
 






anonymous said:
We don't need studies. My studies are on my iPad. I am vps. I've closed millions of cases. I show mortar man and surgeons are amazed. Compliance won't stop me from showing that case, I saved it on my iPad. I'm so clever. Hahahahaha.
And spending money on studies would be giving in. You are missing the point which is this: We don't need studies, WE HAVE THE BEST PRODUCT! Why don't you just say that? I did, read your emails.
Why waste money on a study when I can just tell the reps how bad they are at their jobs? Doing that results in results, and I'm a results kind of guy. Unless I don't like you. Or unless my results are bad, then it is someone else's fault. The only reason sales stopped growing and turnover is awful is because the sales reps are no good, it has nothing to do with strategic decisions or lousy sales leadership and lack of sales training. I will explain in detail why this isn't my fault, I have a lot of excuses for my own results. Look, all you have to do is ask your manager how I did it and then follow the blueprint. I've sold millions of anastomosisoses and that has saved lives. It's not that hard once you figure it out. CRACK OPEN THE SAFE. And if you need help the regional managers are really well qualified and knowledgeable. THAT'S WHY I HIRED THEM. All you have to do is ask. You know what? You are a complainer. If you can't do it I'll find someone else who can.
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This is sad. Company needs to get its act together fast
 






this just in... the traning manager quit today. she was too smart and too qualified to work here. so she went out and found something better. such a shame. does anyone even notice or care???
 


















The VP of Sales is the biggest problem at this company. EVERYONE knows it. We all talk about it. Even his "buddies" from the lone star state openly talk how bad he is at his job. They guy is sneaky, completely unethical, and severely under qualified. Funny thing is that he takes pride in those characteristics.

He's kissing up to the new board and new CEO already and praying they don't fire him. I sure hope they're smart enough to see through his b.s. As long as he's making decisions at the company, Acell will continue to be a disaster like it was in 2015.

If things don't change in the next 3 months I'm looking for a new job... And I know several other high quality Reps planning on doing the same. Fingers crossed
 






I completely agree with the above post. Haven't been with the company long but the VPS is clearly full of sh*t. Everyone rolls their eyes after he talks. If he's our leader for 2016, we're in for another rocky road.
 






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