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Re: formerdtrader post# 8701

Thursday, 11/29/2018 12:16:58 AM

Thursday, November 29, 2018 12:16:58 AM

Post# of 10354
In terms of the short term.... Well. I have heard people say here that because they filed the CE - well that means they have heard back that the FDA is getting ready to send approval. I am not so sure of that. I do think the FDA will approve the 501 easily. But. If your application for the CE is already filled out the best you can...well why wait? It may take up to 6 months to get approved. And when the FDA approves the 501 you can let them know... It could take a little while to hear back from the FDA considering it is the holiday season. And they promised to get out the CE application this year. So why wait. Submit it and start the clock rolling. None of us know the timeline that these government agencies work on. But I will bet my bottom dollar Arch thinks both will be approved. And they may not be approved at the same time. So who knows if they will want one licensing deal or two. But. If they do get approved. Well we may look back and say it was worth the wait and heartache and mistakes. In fact it was a blessing. Not only do they have the added experience of going through the application and approval process - well they were also forced to do an additional test to show there were no sensitivities or side effects. and because some of the products are similar......well if they can get basic AC5 through then I feel a lot more confident about the other products. This isn't their biggest money maker - but it will bring in money. And all the work they have done on it will make it much easier for the other products. But hey. Let's not put the cart before the horse. Let's all hope the 501 goes through with no more trials required.

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