Wicks, I believe you posted this on this MB before. I believe he stated how extremely careful he had to be wh the KFDA Application & their Process. I hope you don't mind me Re-Posting this, I feel this is for the GOOD of this MB. Also, it's a good read on a non-active Day. Boy, I can't wait to meet you guys/gals...Here's Mud in You Eye...Who is this Qoute By??? Enjoy, GTG to Work.
From Paul,
You have to understand that there is a certain order we must follow to make sure we gain KFDA approval or for that fact , any approval from any governing body wherein we will do business. The process is fairly clear in how you submit the product, however, if you make any minor changes then you have to resubmit the product and fill out the information all over again. Then, if the processor gets upset in any way, they will bury you with more and more info and delay the process even further.
I have to insure that we, as a company and for the benefit of the shareholders, submit the amended application so we (1) gain approval as quickly as possible, (2) don’t upset the processor, and (3) don’t make any more changes at all once we’ve amended the original. The original application had some minor issues with the software’s business and reporting functionality. I worked with Sam for over 3 months from June until September, making the necessary alterations to the software so we can insure we have total control over insuring we collect our proposed $19.99 monthly software fee as well as complying with all applicable laws of patient privacy both here in the U.S. and in other countries that are adopting our HIPPA regulations. This was very important because if we had submitted the final device without these, we would have had to go back and resubmit them which would have caused a serious delay.
I think I’ve covered what we have to insure we go through the process with as little feedback necessary once the amendment is filed. We’re working diligently to get this in as quick as we can, but don’t want to end up having to answer questions from the processor on minor things we may have missed. I’ve done this before with other medical devices submitted to the FDA and I feel my knowledge will assist XTend in getting this done quickly so we can move on.
Remember, KFDA is only one part of this whole picture. We’re moving forward in the equine and veterinary sectors but being the holidays and all, it won’t begin to happen until 2010. As for the other countries we’re working with right now, we already have the applications ready to go and merely need to replicate what we’re doing with the KFDA. So it is imperative to make sure we don’t stub our toe on the KFDA, which is why I’m making sure we do this the right way.
As for the human test data, as soon as we’ve finalized the amendment, my plan is to place this information up on the new and improved website as soon as I can, if it passes through our legal without any problem. I just ask that you and the other shareholders be a little patient with me right now and enjoy the holidays. I’m working as hard as I can to insure we set the table for a great run in 2010.
