right, like the FDA neglected to acknowledge this during the other 510k submissions and then waited for this one and went "aha" we need to address this now too. idk what internal parameters changed but seems like the FDA just fucked them and making them redo this again when they could have killed two birds with one stone before....kinda shameful on the FDA

yea i mean FDA is boss so they literally call the shots however they want. really confusing to see a mask being submitted as an implantable device? no part of it is being implanted subcutaneously. would have rather heard from the FDA than Remsleep about what happened

so straange the FDA regarding a CPAP machine as an implantable device

read the posts below us from earlier today.....FDA correspondence is to pull the current 510k and resubmit a new application under an implantable device....back to the drawing board and delays but still the same fundamentals and company

yea that'll be game set and match for now, back to the drawing board and back to baseline to draft this new 510k. no clue how they define a CPAP machine as an implantable device and recommend they go down that route? i work for an implantable monitoring device company for cardiology, similar to a pacemaker, and that is the 510k process we used. odd direction from the FDA. either way.....lost a little here...using the rest towards TCRI which could be massive.....

morning y'all.....hoping for a good week here, second episode of RH of Dubai will air....maybe we see more of Munaf on TV....also in on the oil momentum so lets have a great week and make some money!

you think thats the dip? I feel like it can drop further than that based on last weeks chart. i was going to put a few purchase orders in for like 15.50, 15 and 14.50......then put my sell limit on $30.....

im gonna scoop more next week and set my sell limit to $30 and just ride it out

do you have any insight where you see this in the by end of 3rd quarter and end of 2022? i know earnings look great for august but idk how that translates to share price

hell yea, i gone fucked up and sold yesterday but i bought in again and already in the green again.....gonna load even more when it dips next week

well, this is disappointing, can't keep any traction. hopefully some actual news from the mouths of the captains of the ship will right the ship and send her back on the lovely voyage to financial freedom. until then, good day ladies, gentleman, lentleman. (line from Anger Management; great movie)

you clearly do not come from a scientific background....the pressure can easily be manipulated by a variety of components between the CPAP machine and a humans lungs....

beautiful day here, sold for some profits, will reload when RSI cools off tomorrow or monday...

lol i dont have OSA, just insanely bad year round allergies that severely limit my ability to breath freely so i am usually breathing through my mouth...i go for weekly shots, hopefully biweekly soon....its a pain in the ass getting stuck in each shoulder once a week and the nurses are so hit or miss, some i hardly feel and others jab you right in the muscle...

i know your pain, hence my name haha! goodluck moving forward

bet you feel much better now though....my allergies are so bad its like having a deviated septum myself

ASCENDING!!!!!!!..........

TRIANGLE!!!!!!!............


UNITE!!!!!!!!

happy to hear your positive review of the product, best of luck to you, your health and your financial health!!

thank you, can you post the pic here? i dont have ST

my fiance is a huge housewives fan and because of that, i am forced to watch these programs. After a few drinks, i even get involved in the drama. That being said, Munaf is a very undercover individual, no social media, nowhere to find PR unless he wants something to be known. The first image of Nina on the show was with Munaf, he doesnt seem to be afraid of the camera. With the show starting and the amount of publicity he and his wife are about to get, the last thing he is going to want is bad vibes floating around his reputation....i think we are sitting pretty right now....has nothing to do with the stock but just think he was in the states all week and he didnt tell anyone, his minion did. this guy has it all coming together under our noses

correct, hoping they worked their kinks out

30 days from may 6th

woooooooooooooooo!!!! waiting for some PR

im not on ST or twitter so its tough to see some of these messages but very stoked to see things coming together. Glad i scooped some in the .50s last week to average down....gonna scoop more under a dollar, might be my final purchase before we move onwards and upwards, hoping this one pays off all my student loans and some

would love to see that, will make nice gains from such move

pissedddddd, have a 15 average, shoulda sold at the bell this morning at 15.75 and rebought at 14.....next time this gets above my average im selling and waiting to re-enter, so many swings, so much money to be made, left some on the table today unfortunately

lolzzzzzzzzzzz maybe like a month but still new

Its not complex, i had to submit PMA for my companies IMD. I know precisely how it works, for a single device, it can take years for 510k approval, doesn't matter if it is one being submitted or several, its not like they're starting over. Took 7 years for our device to be PMA approved and now we have sales in 5 continents.

exactly what i said, it can take longer than a year to have a device PMA, takes years of research and trials to get to that submission point, then they can come back with amendments etc, just because you think the 510k submission process starts over, it doesnt, its still all apart of the same device, so maybe you are confused

i know the process, i work for a cardiac device company and our device took 5 years to be approved through PMA, so, yes a 510k can take several years. Maybe RMSLs is different because of the information FDA was requesting but stay in your lane buddy because ive been doing this as my job for years and yearsssssssssss

a 510k submission can take multiple years, as many years as it needs to.

soooo keep buying under a dollar? or hold and wait for further updates?

gigantic bull flag on the hourlyyyyyyyy

keep on inching up there little buddy

kinda expected this on a friday, always dumping on fridays, but hopefully we return strong next week......

yea!!!!!!! wooooooooo!!!!!!! .10 will make daddy some money!!!

would love some green today, found a nice base though

snagged some .55s yesterday to get the average down to 1.25

and now they resubmitted after resolving the cytotoxicity issues. So, wrapping everything up, why are you bearish? why do you think it will not pass fda approval this time around?

do you have literature where it says empirical was overseeing the 2021 submission? the PR is from June 2021 and it says they had grown frustrated and now partnered with them to complete the 510k submission, which i would think is the 2022 submission.....