Uh Oh... 3831 Advisory Committee Meeting in October

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anonymous

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I hope this won't be a reply of the 5461 meeting but it sure seems like it is heading in that direction. How could you guys be caught off guard when the panel said they gonna want to look at drug drug interactions because you have sami on board with olanzapine? Will it be another epic beat down for your company like the bead down ya all got with 5461? Looks like it be shaping up that way.
 



It will be interesting to watch. Severe beat down last time was partially die to FDAs concerns over Alks manipulating data, ignoring FDA guidance on study design and potential addiction potential of samidorphan. That concern still exists even if thee data is pristine. There is at least one study showing no difference between the combo and olanzipine alone in terms of weight gain. So roll the dice and hope this won’t be another bitch slapping
 



anonymous said:
It will be interesting to watch. Severe beat down last time was partially die to FDAs concerns over Alks manipulating data, ignoring FDA guidance on study design and potential addiction potential of samidorphan. That concern still exists even if thee data is pristine. There is at least one study showing no difference between the combo and olanzipine alone in terms of weight gain. So roll the dice and hope this won’t be another bitch slapping
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Reply to you own posts much?
 









I just hope we have some great data on drug drug interactions with Samidorferun and other opiates. If we don't we'll probably be told to get some and come back in a year.
 



anonymous said:
I just hope we have some great data on drug drug interactions with Samidorferun and other opiates. If we don't we'll probably be told to get some and come back in a year.
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I think we will be fine. I can confirm that Renick has been working for days with KOLs and key task force members on presenting to the committee. We are going to be fine people. He can eat, drink and post on ALKS 2 Go like nobody else. Renick for CEO!!
 



anonymous said:
I think we will be fine. I can confirm that Renick has been working for days with KOLs and key task force members on presenting to the committee. We are going to be fine people. He can eat, drink and post on ALKS 2 Go like nobody else. Renick for CEO!!
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Good job Renick. Posting on ALKS2GO on a Sunday morning your work with thought leaders on slide decks. Needing a little more attention?
Whoever said the hospital force is a waste? I say NOT!
 



The hospital team is amazing! They work from 10-2 3 days a week with a 2 hour lunch. With this of kind of effort, imagine the cost savings by cutting all of them and going back to total dirt. It’s amazing we have a hospital team that are never in hospitals and are always asking to be introduced to key providers in the hospitals they don’t work.
 












anonymous said:
I hope this won't be a reply of the 5461 meeting but it sure seems like it is heading in that direction. How could you guys be caught off guard when the panel said they gonna want to look at drug drug interactions because you have sami on board with olanzapine? Will it be another epic beat down for your company like the bead down ya all got with 5461? Looks like it be shaping up that way.
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T - 18 days to the big 3831 Advisory Committee review. So... Do you think Alkermes will have any drug - drug interaction data they will be able to share with the committee? Vegas odds are giving 3831 only a 38% chance of the committee recommending they move forward, 52% chance that the committee sends Alkermes packing and says to come back in 1 year with better drug drug interaction data and a 10% chance it will be a go away and don't come back like they gave 5461.

Your thoughts?....
 



Frankly the track record with the FDA is not good or in ALKS favor. Major bitch slapping for shoddy clinicals, etc on MDD drug which also contains samidorphan last time around. So there will be a built in bias against this drug from the get go. Combine that with the fact that the mitigation of weight gain, etc. is minimal and I think the chances are low. And if it is by some odd chance approved who will pay for it?
 



anonymous said:
Frankly the track record with the FDA is not good or in ALKS favor. Major bitch slapping for shoddy clinicals, etc on MDD drug which also contains samidorphan last time around. So there will be a built in bias against this drug from the get go. Combine that with the fact that the mitigation of weight gain, etc. is minimal and I think the chances are low. And if it is by some odd chance approved who will pay for it?
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Well, that's why we have jobs. It's our job to educate physicians on the product and we have to work in conjunction with our managed markets and health system partners to help them with KOL and physician support to make sure health plans and hospitals and systems will allow its' use. If we can't get physicians to support it then we can't ask our health system partners to get it covered. Just that simple. But that's what we all get paid for. If you can't handle it then leave!
 



anonymous said:
Good job Renick. Posting on ALKS2GO on a Sunday morning your work with thought leaders on slide decks. Needing a little more attention?
Whoever said the hospital force is a waste? I say NOT!
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Renick is ALKS biggest blow hard. Is his bigger contribution the selfies or the free drug he gives away?????
 



anonymous said:
Frankly the track record with the FDA is not good or in ALKS favor. Major bitch slapping for shoddy clinicals, etc on MDD drug which also contains samidorphan last time around. So there will be a built in bias against this drug from the get go. Combine that with the fact that the mitigation of weight gain, etc. is minimal and I think the chances are low. And if it is by some odd chance approved who will pay for it?
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The concern over abuse potential with 5461 was for bup, not sam. It’ll be approved, there’s no reason not to, but I agree nobody is going to pay for it. I’ll beat down every door in town but I’m not hopeful.
 



anonymous said:
The concern over abuse potential with 5461 was for bup, not sam. It’ll be approved, there’s no reason not to, but I agree nobody is going to pay for it. I’ll beat down every door in town but I’m not hopeful.
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there is concern over sam because it’s an opioid antagonist and might throw patients into withdrawal if they have an opioid in their system when started on 3831.

if this concern was not fully addressed during the 5451 debacle, then it will be fully addressed Oct 9.

if there’s not enough safety data then the fda will ask for more, which will take time and money and will lead to another round of layoffs. for anyone counting that will be two consecutive years of layoffs.

if all the safety concerns are addressed to the fda’s satisfaction, it will get the recommendation and the approval.

if you’re not hopeful about it’s prospects, you should consider finding another job you are hopeful about, or changing your attitude about this job. what you believe will happen affects what will happen and customers pick up on this. attitude is more important that “beating down every door.” beat down every door with a bad attitude and you’ll get a bad result at every door. much more likely to get a good result if you open every door with a good attitude.

good luck to you and good luck to ALKS on October 9.
 



anonymous said:
Well, that's why we have jobs. It's our job to educate physicians on the product and we have to work in conjunction with our managed markets and health system partners to help them with KOL and physician support to make sure health plans and hospitals and systems will allow its' use. If we can't get physicians to support it then we can't ask our health system partners to get it covered. Just that simple. But that's what we all get paid for. If you can't handle it then leave!
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You might want to email this to the hospital sales force....... they didn’t leave their house pre pandemic. My HBM doesn’t know the difference between Maintena & Aristada, she’s great!!!!
 



anonymous said:
You might want to email this to the hospital sales force....... they didn’t leave their house pre pandemic. My HBM doesn’t know the difference between Maintena & Aristada, she’s great!!!!
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Aristada was the Greek philosopher
Maintena is a confluence of strategies that ensure an item works as expected when needed

- Local HBM
 




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