GREY:IPHAF - Post by User
Comment by
bromley1877on Jun 26, 2010 12:54pm
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Post# 17224611
RE: Some thoughts
RE: Some thoughtsProfessional, that doesn't make sense to me. surely they would not approve the drug in the face of unresolved issues even if they thought they could be resolved. And even if they resolved them internally somehow, why would they now not need a meeting.
They called a meeting because they felt they needed one before approval. There may be rare cases where it is so clear cut they cancel the meeting because there is no need for one. But here they cancelled the meeting for precisely the opposite reason - because there were issues. I tend to agree with the view that what they are mulling over now is whether they are resolvable or not within this particular submission. If they decide yes then the meeting will be rescheduled for a different date. If they decided no then the application will be rejected and Lux will need to resubmit afresh.
If I were desperate for a straw to clutch I would glom on the words "as needed" instead of "if worthwhile" or "if the application proceeds". An optimistic view is that those words suggest that a meeting may not be needed and approval might issue without out one. However to take that optimisitc view you have to totally ignore the fact that there are these issues and they are what led to the meetings cancellation i.e. the meeting was otherwise something that had to take place before approval