RE:RE:RE:RE:WuXi newsPoorOpinion wrote: SPCEO1 wrote: PoorOpinion wrote:
Actually thinking about it, from his CV, you would think this guy might have insight into how the manufacture assessment might was going. If not directly then maybe through some very close contacts.
(did I use enough mights and maybes?)
Approval is a near certainty but this makes me think the chances of a imminent approval has fallen. I have to think this reflects a reaction to FDA concerns and it might take time to sort it out. Just guessing but that is not the news I wanted to see given the implications for the timing for approvals.
You probably make these appointments to plug gaps but to some extent we know there were gaps, that's why they had to submit extra info in 2017. The appointment of senior personnel probably takes some time (at least a month, idk) so I dont think this is a reaction to something immediate, but I get your point its hard to spin it positive, maybe no need to spin it too negative though.
I mean if the FDA have asked to have certain processes put in place, and WuXi are complying, then it would be natural to include the appointment of certain personnel as part of that process, it could show that meaningful change has happened which would be a positive.
So in my mind the positive scenario assumes WuXi are competent.
In August they get the news there are deficiencies and have 3 month deadline to re-submit.
Existing management endeavour to fix the gaps, no time to find, appoint and embed new leadership. We know they submitted the new data on time, which is a good sign. Having dealt with the problem you appoint extra leadership to ensure better oversight in that area going forward. You would think the FDA were clear in what was lacking, existing management should be able to take the lead from that and make the appropriate changes.
If you think they are cowboys. They get the news in August, throw together a new dossier, are now getting negative feedback and panic appoint new leadership.
Of course it could be anything inbetween.
My memory is that WuXi leadership has good pedigree, I'm favouring the first scenario. The timing of the appointment looks scary from our perspective but could also be part of the end game of the good changes that happened.