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How long is a 510(k) review?
Almost two out of threel 510 (k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510 (k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests
I remember when I emailed Tom Wood and he told me he would never dilute on shareholders (O/S was at like 30 million and A/S 1 billion)...that was 2.5 years ago and look at that...100's of millions diluted and A/S raise to 3 billion...reverse split is coming here if/when that FDA approval ever comes...BUYER BEWARE $RMSL
It sure looks like it. I jumped between spread yesterday and filled quickly. Figured they are causing a little panic with the spread. Somebody dumped quick twice above the bid as soon as i put order in
Somebody is loading up. Its been a long time coming.
Sure looks like this is being deliberately held down with majority of transactions being buys. Somebody trying to hold it back it seems… bulish RMSL!!
I wouldn't count on that due to the "Sell on news" crew. Tom has been working on this for years and he is very close to FDA approval (IMO). I look forward to the next steps after approval. GLTA IMO
How would anyone know, when they just released the good news?
In the past this used to take a day or two to react to news in a positive way, but that was a few years ago. We shall see!
Guessing bad news coming based on todays negative close with such a good PR??
Great news...bring on the FDA approval and lets see this thing get some legs! GLTA
Tampa, FL, Jan. 05, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- REMSleep Holdings, Inc. (OTC PINK: RMSL): The company announces that testing for ISO 18562-4:2017 has been completed. We are actively compiling all necessary documentation to submit the analysis to the FDA to proceed with our current 510k application. Further updates will be forthcoming. We look forward to concluding our 510k application with the FDA very soon.?
Are we there yet ???
Time must be near for this rocket to launch!
Float is relatively small considering the potential of millions in return.
Have a GREAT RMSL holiday everyone!
Only about 150,000,000 shares added to the O/S since 11/12. But sure, keep saying the L2 doesnt show dilution
Next pop looks like it will touch .02.... irrespective of news.
4 weeks ago they had a pr saying testing will be completed in as soon as 4 weeks. So ultimately, any day now we could know the required testing is completed and sent to the FDA. Then as soon as the FDA can review it is as soon as we all find out it's approved.
Anyone have a timeline for approval here?
Yes,it cost them over$82k!
A nice 5 million buy, someone wanted in.
Seems to be going just fine, thanks
$RMSL
Yes agree, it will continue to move higher as we get closer to info re testing. If positive which I believe it will, they it will move much higher pretty quickly.
This could move up quickly.
Getting closer to hearing news re condensation testing, could come within the next 2 weeks, then off to FDA for approval.
Sellers out for now? Time to ramp up !
$RMSL private share offering is rarely a concern for current shareholders since it requires the buying investor to commit to a 6 or 12 month lockup, and, you usually have to pay a minimum amount purchase (e.g. minimum $20k worth of shares in a block).
so even if say all PP offered shares are bought, you won't see any of it sold in the market for 6-12 months.
This is a healthier way to do a cash raise vs going the toxic loan route. That is how it's done on the big boards from pre-ipo to post-ipo.
$RMSL -there's no dilution on L2....hilariously incorrect.
So is it turned off with the price going up or is it on with the price going down?
I can't keep up with your ever changing synopsis
Hows dilution going?
OS as of 11/12 -
1,039,422,364
Up substantially and expect it to continue to move higher while the price moves lower
the only point u have made is u don't understand the public equity market.
it just amazes me that folks trade these otc stocks and have zero clue what they are doing.
$RMSL -u don't understand how these offerings work homie. anyone buying at the discount rate has a 6 to 12 month lockup on shares. it's not a debenture or other type of toxic convertible note, it's a straight up equity offer.
if some are not buying RMSL because of this rather normal and healthy capital raise offering, well that's just goddamn hilariously incompetent.
Thank you for understanding that it's old and accounted for a while back.
Its not from "years ago." Its from June homie
Additional 250. Thank you for your understanding. Original 290 was already there. Why not bring up the other offering from years ago if you're playing that game.
It's stupid, that's why.
Yes...total of 540M thank you
That initial offering was old news. It's an extra 250 however you want to spin it. You were wrong, again. Move along
Thank you for making my point for me. It's 540M regardless of how you want to spin it.
And it's adding 250,000,000 not 540. 540 is the total after the amendment.
Your information on here is severely lacking.
Nothing like some pr to help. This will make it's way back up before approval
nothing like some dilution to destroy shareholders!
nothing has changed with the active submission track. i do a lot of med / pharma plays. asking for another test, or even re-submitting a test, is commonplace. asking for a test does not alter the submission track at all. its the FDA's job to be thorough.
if it were "denied" as some morons want us to believe, the FDA would not have asked for an additional test - they would have just closed the submission request and told them to re-apply again later. did anyone see that happen? no.
as for timeframe- the stupid crowd thinks this is going to be wrapped up in a few weeks. this process can take several months. the payday is worth the wait. unfortunately for some, the term "waiting" means 2 weeks tops... lmfao!
$RMSL The story has not changed here- all that changed is the MM washed out a lot of dumb people and their shares went to smarter hands.
It’s not that black and white. They need additional testing/ information. It’s neither approved nor denied. It’s in between submitted and approved/denied.
here's another fact, one cannot argue with a stupid person because they will drag you to their level then beat you with experience. heh
let the morons sell.
the opposite of smart is....
lol...NOT a fact in any way other than in the fantasy section of your mind.
you cannot make things up and try to pass it off as fact. hilarious.
$rmsl
Yes the condensation test which is a new requirement due to the Phillips recall.
You stated 510k denied which is not the case, this application is still ongoing and I expect will not take long to get test done and device approved pending result of test.
Denied Implies they have to start 510k process all over again with a new submission, that is not the case.
Yes - the 510K has not been withdrawn....but it won't be approved in current state because more testing is required.. The opposite of "approved" is..........
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REMSleep Holdings, Inc. is engaged in the business of developing and distributing sleep apnea products. The Company focuses on offering optimum compliance and comfort for continuous positive airway pressure (CPAP) patients. Its DeltaWave CPAP interface (the DeltaWave) is a device to treat patients with sleep apnea. Its DeltaWave product is a nasal-pillows type interface that is designed with airflow characteristics to enable patients with sleep apnea to breathe normally. Its product is manufactured by mold makers. Its target market includes home care dealers, private sleep labs, product end users, sleep physicians, medical groups, sleep product distributors, hospitals, medical associations, such as the American academy of sleep medicine and the American sleep association. REMSleep LLC is its wholly owned subsidiary.
INDUSTRY
Medical Equipment & Supplies
CONTACT INFO
2202 N. WEST SHORE BLVD SUITE 200
TAMPA, FL
33607
United States
+1.912.5902001
https://www.remsleep.com/EXECUTIVE LEADERSHIP
Russell Finlay Bird
Chairman of the Board
Thomas J. Wood
Chief Executive Officer, Director
Jonathan B Lane
Chief Technology Officer, Vice President
https://www.fundable.com/remsleep
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