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anonymous said:
One outlier patient took a failed trial a made it an efficacious drug. One patient that the FDA said should not have even been in the trial. Seriously, Alkermes....... Maybe starting the advisory committee meeting by telling the FDA how they interpret results is all wrong is not smart. It's like trying to sell to a doctor but starting your call with, " You are stupid, doc. Now let me share with you my product"....
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That's the Alkermes typical arrogance. The "culture" that was Alkermes is dead and buried.
 


















anonymous said:
We'll see, but the FDA doc goes a little overboard in their criticism. They bemoan the MADRS6, but the results were significant for both MADRS6 and 10 so it is a moot point. Lots of talk about the SPCD, but the stats division didn't have much issue with it. Lots of talk about abuse liability, but the abuse division was fairly positive in their assessment. 50% of antidepressant trials fail - even for drugs that work (prozac took 13 years to get to market). The BUP/SAM data is consistently positive across all but one trial.

The street assessment has been that there is 30-50% chance of approval. I don't think this document changes those odds
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I think the document changes those odds... And so did the FDA advisory committee. Idiot.
 






Pops listen up.

Let this POS go.

Everything invested to date is already gone. Sunk costs. Move on.

The FDA is not confused about 5461 study design: Alkermes is

Plenty of room for growth potential left for Aristada and A TON of growth potential for Vivitrol if you would ever once and for all hire enough people to properly promote and support Vivitrol (another 100 in various roles should do it). Take whatever $ you were going to use on 5461 and apply to an actual Vivitrol expansion, the ROI will be there.
 












anonymous said:
Pops listen up.

Let this POS go.

Everything invested to date is already gone. Sunk costs. Move on.

The FDA is not confused about 5461 study design: Alkermes is

Plenty of room for growth potential left for Aristada and A TON of growth potential for Vivitrol if you would ever once and for all hire enough people to properly promote and support Vivitrol (another 100 in various roles should do it). Take whatever $ you were going to use on 5461 and apply to an actual Vivitrol expansion, the ROI will be there.
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When I want your opinion I’ll ask for it!
RP
 












We just became a takeover target. There’s no future for 5461. RP won’t be able to turn down a reasonable offer. Vivitrol has room to run in the right organization. The oncology pipeline is really promising but we have no experience developing or selling oncology products. Aristada is a me-too but someone would take it.

I give it a year at the most. Someone buys us for Viv and spins off everything else to the highest bidder.
 






We are done. Yeah, we have Viv, but I agree, we will be bought soon. All of the 5461 staff will all be gone by mid February with a six week package. The problem with this company is we have idiots that have worked here for 15+ years and they have no idea what it is like to work in a real Pharma Co. they also do not want to change and push out anyone with good ideas. RP better sell and retire while he still can. I think his broken promises is old news to everyone.
 






























sont be a dick. There is an expansion for Aristada. That will continue. The 5461 expansion will not. And there are other products in the pipeline. Hopefully those studies were done properly so we don’t get birch slapped again by FDA
 






The Aristada expansion will be a fraction of the original plan... Forecasted revenue from 5461 was factored into the expansion... The organization will probably take 3-4 months to regroup and I'm sure ZS will be a part of that process.
 












anonymous said:
sont be a dick. There is an expansion for Aristada. That will continue. The 5461 expansion will not. And there are other products in the pipeline. Hopefully those studies were done properly so we don’t get birch slapped again by FDA
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I think the reason the studies weren't done "properly" is because the drug was not efficacious. We needed to pool data and change mid trial because that data manipulation was the only way to show the drug was effective. One panel member even accused us of including an outlier to show the drug is effective when that outlier should have clearly not been included in the study. SOmetimes the studies just show that the drug you came up with is just not effective. My question is less about what is going to happen with the expansion and more about who was responsible for this MAJOR screw up?!!! The FDA told us not to pool data, use the other MADRAS instrument... and time and time again we ignored them. How could this decision be unexpected or a complete surprise. Are we that arrogant? Someone should be fired over this.
 












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