May or not be confidential mate, I tried to track down the ‘costs’ of resubmitting for approval, there were several tables with the costs involved and unless of a major nature should not a big concern, imo.
No clue in the quarterlies outflowing either that I could trace.
B-R, sure the science is quite sound, TGA way erring, seemingly, on the side of caution!!, could not find any further incidents of adverse effects.
Regardless of the product, sure many existing products have had a adverse incident in their life span, albeit with a emerging speccy it can be damaging from the point of view of perception.
Major pharmaceutical companies have had law suites against them that are ‘huge’!, nature of the beast, even gaurdisil I believe (?).
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