I expect delay to be around 12 months or a little longer assuming we can pass inspection by end of year. I am sure some of the Reps have already reached out to BMS and I would expect we will lose some reps in the near future.
I expect delay to be around 12 months or a little longer assuming we can pass inspection by end of year. I am sure some of the Reps have already reached out to BMS and I would expect we will lose some reps in the near future.
All avoidable.
The people in Braine manufacturing knew there was a problem since forever and decided to ignore it and pray for the best. FDA saw the issue and the "fix", didn't buy the BS during the inspection and didn't by the BS response to the 483 that was senior management (QA and business) endorsed. All this is supposed to be secret but the company in buzzing with talk coming from Belgium
This issue was known about and entirely fixable and preventable....wonder who will get fired and how long the delay will be and can the external consultants put lipstick on this pig.
So who is to blame for this latest stellar performance?
I thought the S&TS webcast would provide a distraction to the dire Jubilee celebrations we are having to endure in the UK. I was wrong!
A controlled and nervous presentation by Kirsten and her team. Stef describing it as an unforeseen bump in the road, fuck, if they had looked in his area, they would have had a riot. He would have descrbed the car crash that would have resulted as a minor scratch that could be polished out!
Have our glorious S&TS and QA leadership forgotten that there was a similar observation for dripping needles for Keppra a few years ago and it will be in the EIR. So, this was known about and was completely avoidable. Dripping needles and wet stoppers have always been an issue for the FDA that even some of us in development know about and the FDA website is full of 483 observations for this type of issue, but Braine manufacturing and Jaques know best and QA leadership is too weak to tackle the serious issues that exist in this company.
Back to my beer now I have vented my spleen
I thought the S&TS webcast would provide a distraction to the dire Jubilee celebrations we are having to endure in the UK. I was wrong!
A controlled and nervous presentation by Kirsten and her team. Stef describing it as an unforeseen bump in the road, fuck, if they had looked in his area, they would have had a riot. He would have descrbed the car crash that would have resulted as a minor scratch that could be polished out!
Have our glorious S&TS and QA leadership forgotten that there was a similar observation for dripping needles for Keppra a few years ago and it will be in the EIR. So, this was known about and was completely avoidable. Dripping needles and wet stoppers have always been an issue for the FDA that even some of us in development know about and the FDA website is full of 483 observations for this type of issue, but Braine manufacturing and Jaques know best and QA leadership is too weak to tackle the serious issues that exist in this company.
Back to my beer now I have vented my spleen
this is what happens when QA is week and survive by playing politics and appeasement “don’t upset the business..” “ensure the metrics are green”. All too predictable and all too avoidable
Pretty clear the head of QA has no clue on what a quality issue is. To whitewash this and suggest it is a "one off" is absurd. The next debacle will be with "rozimab" and shortly after that the Boston acquisition zilucoplan. Ownership begins at the top. Start with head of QA and work backwards.why can they not just tell the truth about what happened? The townhall Q&A was a joke, someone screwed up and they know it
