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10:26
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Originally posted by nogur1223
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Obviously FDA will be the crown jewel, which will see the share price increase exponentially following it. However, I am not as confident that we will get it as I was for CE/TGA (harder regulatory process/average US results/inability to use AU trial results in the application). I wouldn't be surprised if they come back to us and tell us we need more trials to be done in the USA. I have held other stocks (AVH) long before they got FDA approval and it was a painful process. Nevertheless, I don't necessarily think that is a bad thing. We have CE/TGA and now we are on the road to commercialisation/deals with prospective partners in Europe and Australia. The news flow that is expected from this, as well as the increasingly successful Sleep Apnoea arm of the business, will ensure that the SP doesn't suffer for too long following a negative FDA approval. Further, the US market is a different beast. With the limited cash we have, entering multiple markets at once could be detrimental to the health of the business. It wouldn’t be a bad thing if we have to just focus on EU/AU market, then expand into the US later on. Regardless of what happens in the FDA decision, I am confident that we are destined for success in the medium to long term. I look forward to the exciting months ahead.
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Nothing at all wrong with the US results when compared to what is currently available. I suggest you do some more research before you start your gloomy FDA predictions.
