More than likely no. Still haven't heard for sure as of today. The complete response letter is still being reviewed by Otsuka. I don't think decisions have been made yet until they know more about timeline for correcting the sterile water issue.
months. otsuka has to respond and the fda has 3 months to respond back. isnt someone communicating this to you. this is basic info. call the dsm for gods sake. how do you not know this
Managers just completed training last week. Otsuka reps on-boarding next week. October launch meeting has NOT been cancelled. Hopefully we can start soon. But we will see.
Confirmed that Area Sales Managers just had a Abilify Training Meeting this week and the Launch Meeting is still on and not cancelled. Good chance h2o is resolved quickly according to Otsuka VP. These are the facts from the Training Meeting this weekend.....those who are bitter for some reason (maybe did not get a job offer) throw out lies.
Of course they are going to tell you what you want to hear and what will keep you from jumping to another opportunity. It keeps them from having to go thru the recruiting again In fact, no one knows. FDA will make their decision when they want to. It could be 3 weeks, or 3 months or even longer. Otsuka will go thru the motions as if everything was right on target and then when it gets close to the launch and there is no approval they will postpone it,
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.
Otsuka meets with the FDA next week. Perhaps they are bringing some CiZash to the table to resolve the "cloudy sterile water" issue once and for all? This drug will get approved too much riding on it for both companies.
Sure it will get approved, but when is the question. I've seen other companies try a late November/December launch and its just a really tough time of year. They would be better off to wait until January at that point, that is if they can't make the October 1 deadline. Then the problem becomes, how many newly hired reps wait until then?
So the product is delayed??? For how long?? IF it is too long most reps willl move on and they willl need to reintervewi new people.