Ann: Update on US FDA De Novo Classification Request, page-62

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Owen67

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11/03/20

10:39

Post #: 43421710
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Originally posted by eason2946: ↑

Hi all,

It's disappointing to see this news today, definitely not what we were expecting. Like many others have stated, you gotta wonder how can the same product be 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.

As stated in the announcement, RAP will meet with FDA in person and hopefully resolve any doubts the FDA review team has for the product.

To me, this feels different than the failed clinical trials years back. Because now we have proven algorithm that's actually working and can be used for other commercialisation opportunities in Europe and Australia. All the best to fellow Rappers.

GLTAH.

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I reeks of American protectionism...or just plain stupidity. You have to remember RAP will take its earnings from existing entities..ie Radiology.

It would put a big dent in their coffers...they don't want that. I smelt a rat the last time...smelling that same rat.

RAP Price at posting: 6.9¢ Sentiment: Buy Disclosure: Held
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Ann: Update on US FDA De Novo Classification Request, page-62

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