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mr sano, you have been preaching CONSULTANT, now it's here, what's next on the say no agenda?
High of .218, only 4.8cents off!
How does one FIRE a client??
Unbelieveable!, You assume they don't check out there clients product? They have credibility to protect, and I doubt would accept a pipe dream!
Glad to see you back! And yes this is for real thx!
I see they have experience with FDA medical device apps.
Posting doomsday scenarios might make you feel better, but it doesn't jibe with your previous ex "large shareholder" statement and will have no effect on the outcome!
A public access link will do just fine!
It's a shame, bashers don't have to be certified. You have no idea why the nse was reached, including being far better than predicates! Yet, you attempt to discredit Dean.....classy!
adrian, you claim Dean is not capable of designing the DVIS "which is BS". If you could kindly post your bio, so we can decide if you are even qualified to attempt to make these accusations. Your intentions seem far from a concerned ex-shareholder!
dayneyus, according to this article, a low risk nse letter should contain the information on which avenue is best. I wonder if it is on Dean's letter?
mugs....curious as to your opinion on the nse? Is the device lacking something "I can't imagine what compared to predicates", or is it far superior to the predicates, or something else?
Gee, I wonder where you heard that? I wouldn't believe that for 1 sec!
Let me see here....believe you...or...Dean? Can you post facts on your FDA image beliefs?
So, now you know who is buying and why? I wish I had your ESP, I'd be buying lotto's!
I demand he brings it to each shareholders house! Oh, that could exclude some posters!
Well all, it appears that the "mod squad" is set to get to the bottom of things, hehe, I am waiting patiently!
.0103 hah!
.0005 is even safer LOL, doesn't mean you can get it for that! You can always dream!
adrian says we can get em for .01, sorry!
I don't think a gandry is part of the machine?
adrian.. could you tell us what "black box" testing involves?
OKIEDOKIE adrian, I must ask..why are you spending so much time on a theory stock??
Didn't say it wasn't part of the process, re-read please!
WOW, so much info! Off the shelve parts, NOT technology. I'm sure the gantry is plenty fast enough, besides, it's not the gantry speed that produces realtime!
Precisely! Didn't say it doesn't work did they?
Dean said he was not divulging company info on Facebook! Please use correct quotes!
Why are you assuming there is something the FDA doesn't like? This is not a decision saying something is wrong, they are saying it's not equivalent to predicate devices, which ,if it is better, and uses different technology, would be a likely outcome. It can be better and NSE!
He is not alone having trouble seeking FDA approval!
OK, here's a new question. Who here has never made a mistake or error? Lucky for most of us, Dean has the gonads to move ahead!
Let's see a show of hands, who here has had a smooth 510k submission? Oh, my bad, ANY 510 submission?
Now there is a good point? Is it possible Dean stole the images from a hospital? YOU have got to be kidding!
Why would the FDA need trials, the exposure can be and was measured.
Maybe Dean could send us all a copy of the letter? yeah that's it, I'm not buying another share till I talk to the branch guy or Dean brings the dvis to my house.......geez!
adrian....I wish I could say you are MORE ON the right track, but I can't!
It's not a matter of acceptance, it must be Substantially Equivalent to the predicate device.
ndforlife, I gotta agree! This avenue of contacting the Branch chief, is for resolving an issue where a co. feels there is a leastburdensome way of submitting information the FDA has requested. Again, they have made no request, so this is not an available option. They told us it's still under review..for all we know the BC already has it?
Joe, I understand your concern, but there hasn't been any issues brought up by the FDA, they are reviewing. This avenue is used when providing info to the FDA can be dealt with in a shorter time frame....they haven't asked for anything. JMO