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Anonymous said:
For anyone on this thread that cares about facts here is what we are talking about.
A complete response letter indicates that the review cycle for an application is complete and that the application is not ready for approval. The FDA starts a new review cycle afther the resubmission of an application following receipt of a complete response letter from the company. A resubmision is a submission to an NDA that purports to answer all of the deficiencies that need to be addressed by the applicant before approval as set forth in a previous action letter. More than likely we will qualify for a class 1 resubmission. Now you may ask what is a class 1 resubmission. Well I'll tell ya. A resubmission of an application or efficacy supplimental that FDA classifies as a class 1 resubmision constitutes an agreement by the applicant to start a new 2 month review cycle beginning on the date the FDA receives the resubmission. That my friends is why you are hearing a 90 day possible delay. The faster we turn around the response the faster the 2 month review cycle begins.
And to the above poster that believes that any old sterile water would work, your an idiot.
Hope this helps clear things up a bit. Straight from the inside!!!
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Straight from the inside with some more for you all. 90 days now looking like a pipe dream and folks here coming to terms that it will more than likely be after the first of the year until FDA action. Unfortunately the problem is not with the drug but the sterile water that is used during the injection. This ads a whole new complexity in that the injection components are handled as device which is a separate part of FDA and the two groups don't communicate and play well with each other. Get the picture now? Not an easy fix! Now the bad news if that wasn't enough. In that each of you new hires in the field is costing around $350,000 a year in total comp and benefits, it doesn't take a rocket scientist to figure out that tablet sales aren't going to cover your cost. Draw your own conclusions here. Anyone even remember the Lilly Relprev sales force? Disclaimer- the previous views and commentary do not reflect those of Otsuka Management and what you are being told by your managers and I am not down the hall on a different floor.
 






Please advise how it is costing 350k per year per depot employee.

Salary - $100k

Benefits - $25k

Administrative - $20k

Other $ 10k

These figures are rather generous as well. Is there an extra $200k of costs that we dont know about?
 












O.K. so administrative costs, health benefits, and other = $55,000 over salaries.

I did not know that fuel, maintenance and training costs would be an additional $200,000 per employee over salary and benefit costs.

What vehicle do you use? A Boeing 747 ?

Your $350,000 number is way off base. $200,000 per year is probably much closer to the actual number. I do agree that it is still a lot to pay employees for not working and am worried if depot isnt approved soon.
 






Anonymous said:
Straight from the inside with some more for you all. 90 days now looking like a pipe dream and folks here coming to terms that it will more than likely be after the first of the year until FDA action. Unfortunately the problem is not with the drug but the sterile water that is used during the injection. This ads a whole new complexity in that the injection components are handled as device which is a separate part of FDA and the two groups don't communicate and play well with each other. Get the picture now? Not an easy fix! Now the bad news if that wasn't enough. In that each of you new hires in the field is costing around $350,000 a year in total comp and benefits, it doesn't take a rocket scientist to figure out that tablet sales aren't going to cover your cost. Draw your own conclusions here. Anyone even remember the Lilly Relprev sales force? Disclaimer- the previous views and commentary do not reflect those of Otsuka Management and what you are being told by your managers and I am not down the hall on a different floor.
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So what will happen to the Lundbeck reps that were hired?
 










































We need to start bringing some money in the door or we will be heading out the door. I know what I am costing each month and no company can continue to pay folks for busy work and no revenue generation.
 






Fact - there will be no depot before February, if that. I am getting my resume updated again. The question is whether other companies will look poorly on leaving a company in this situation or not.
 






Anonymous said:
Straight from the inside with some more for you all. 90 days now looking like a pipe dream and folks here coming to terms that it will more than likely be after the first of the year until FDA action. Unfortunately the problem is not with the drug but the sterile water that is used during the injection. This ads a whole new complexity in that the injection components are handled as device which is a separate part of FDA and the two groups don't communicate and play well with each other. Get the picture now? Not an easy fix! Now the bad news if that wasn't enough. In that each of you new hires in the field is costing around $350,000 a year in total comp and benefits, it doesn't take a rocket scientist to figure out that tablet sales aren't going to cover your cost. Draw your own conclusions here. Anyone even remember the Lilly Relprev sales force? Disclaimer- the previous views and commentary do not reflect those of Otsuka Management and what you are being told by your managers and I am not down the hall on a different floor.
Click to expand...

Why don't you stop blabbing your fucking mouths off. Stop your bitching
 






Anonymous said:
I think you wish is coming true. Just heard from the inside that we are being trained to sell tabs starting Oct 1. Depot not coming until next year.
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That is not true. I don't know why you all are so concerned. It WILL come out. It's just a waiting game. They are not going to fire you. You're getting paid to basically do nothing now. I'd welcome a bit of a relief from all this pressure we are under to sell tabs with all these generics out. Be happy!!!
 






Anonymous said:
We need to start bringing some money in the door or we will be heading out the door. I know what I am costing each month and no company can continue to pay folks for busy work and no revenue generation.
Click to expand...

This happened when we were first hired before Abilify came out. It was far worse of a situation as we weren't sure the drug would even be approved. This will be approved. Stop bitching and enjoy being paid to sit at your desk a few hours on teleconferences. What a nice gig making 100K doing that.
 






TOTAL micromanaging at this Company. FAR worse than Big Pharma! Their "metrics" are out of control. The bonuses are terrible too. You can be in the top 5, and you only make like $1,000 more than someone in the middle. They do NOT pay for performance. The bonuses are awful.
 






The Lundbeck reps are at risk. The Otsuka reps aren't. Otsuka has more money than they know what to do this and they are cheap as shit. They won't fire ADF reps. They are being paid to train and retrain and listen to teleconferences. They have it easy now until the drug gets approved which it will. Lundbeck--different story. They don't need them too.
 






Anonymous said:
The Lundbeck reps are at risk. The Otsuka reps aren't. Otsuka has more money than they know what to do this and they are cheap as shit. They won't fire ADF reps. They are being paid to train and retrain and listen to teleconferences. They have it easy now until the drug gets approved which it will. Lundbeck--different story. They don't need them too.
Click to expand...

Wrong! Lundbeck never hired any reps!
 






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