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clock Created with Sketch. 11/03/20
11:18
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Originally posted by eason2946:
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Hi all, same product b e both CE and TGA approved , only to be rejected by FDA ? I'm puzzled as to what 'risks' that could significant outweigh its benefits and led to rejection. I believe there's more to the story behind the scenes and it might be the US trying to look after their own interests. It'll be good for the BOD to do some Q&A with its shareholders to further understand the rejection. No doubt today's SP will be hammered but having both CE & TGA approvals, it actually makes me think there's an issue with FDA, rather than RAP's product.
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FDA is a stricter regulator and puts way more focus on efficacy than CE. TGA is just a gimmick that will approve anything that is CE or FDA approved. FDA wants to approve stuff that it thinks is safe, otherwise it opens itself up to legal challenges. I don't buy that they're fulfilling a protectionist agenda as some have suggested, they clearly have genuine concerns.
