Uh Oh
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oh don’t be a buzz kill! It’s a great drug, great company, great science. What does the GDA know anyway?
Sleep tight!
Sleep tight!
And we here at Princeton One are working our tails off trying to get you all set up for interviews. We are the most talented and professional recruiting firm in the Pharma industry hands down.
Fingers crossed for a positive outcome. Patients need new alternatives!
Read the FDA briefing documents which are public record. Looks like the agency has some concerns about study design, efficacy, safety and bup. Oh well, Aristada and Viv will save the day
chin up bunky! Great science, great reputation with FDA and great leadership. We will ram 5461 through. What does an Advisory Committee know anyway?
Donald? Is that you? Stick to Twitter and stay off Cafepharma.
Who wants to take buprenorphine to get high??
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That’s right, nobody wants to because people don’t seek out that molecule to get “high”. Sure there’s abuse potential but it’s not oxy or hydro. People just need to get over the stigma and look at then benefits. Schedule 3 drugs are easy to prescribe, buprenorphine being one of those that doctors aren’t afraid to write.
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That’s right, nobody wants to because people don’t seek out that molecule to get “high”. Sure there’s abuse potential but it’s not oxy or hydro. People just need to get over the stigma and look at then benefits. Schedule 3 drugs are easy to prescribe, buprenorphine being one of those that doctors aren’t afraid to write.
A couple of things in the FDA briefing document are alarming when i read it. First, they say they they explicitly told alkermes it was not a good idea to shorten the patient survey and you guys did it anyway. The wording in the document discussing that part of the study design was terse to put it mildly. Second, they clearly said the data analysis design is very new and seems to have been needed to show efficacy. They clearly are not sold on it. With two failed study arms and a negative study arm this was the only arm that showed efficacy (separation from placebo) and that "new" design seems to have been needed to show it. Strike two! Finally, the FDA briefing document clearly says that adding sami to bup does not on its face prove it removes the addictive property of bup (said that had clearly NOT been established). That was all in the first few pages of the FDA briefing document that was posted at the beginning of this thread. Thanks to whoever posted that. I've been in interviews with you guys since that was made public and none of your DM's or should I say DBL's interviewing me brought that up.
I'm afraid that this product has little chance of being approved anytime soon after reading the FDA document. For good reason! I feel like you have wasted my time. I hope I am wrong. Actually, I'm not sure. After getting the FDA perspective I am not sure I would want to sell this. I think you guys need another efficacy study with more traditional study design to really prove the efficacy. And much more substantial data on addiction and abuse potential is needed. Until then, I can't see the FDA seeing the reward/efficacy enough to over come the risk/addiction potential to actually approve this without a lot lot lot lot lot more long term data. Our country is in the middle of an opiate epidemic for great given gundrums sake.
Use that logic tomorrow at the Advisory Board Meeting. CertIn to work. Drug won’t see light of day in 2019. But keep on hoping
Yes you read it correctly. kind of scary isn’t it. Particularly the part about ALKS trying to use an abbreviated form of the MADRS scale. The study methodology was wrong all along. It maybe the best drug ever but it won’t get a favorable review tomorrow at the advisory committee meeting.
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
The street assessment has been that there is 30-50% chance of approval. I don't think this document changes those odds
Actually it’s a Pooper. Where you at now Jim Kramer. There go our options
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"....
Bitch slapped for sure. Well deserved. So sad that we were sold a bill of goods on the pipeline. Fooled many of us but could not fool the FDA today. I’m sure the usual emails will flow about how we will go back and appeal, telling us what a wonderful place this is, blah blah blah blah!