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Thinking the news we see at some point this week is going to be FDA submission related. Just have a hunch. I think they got the test results back last week and that is why you saw the spike in buying interest. It's very likely the 501K consulting company is already reviewing and doing their final pass of the documents with the expectation that all will be resubmitted back to the FDA by the end of the week.
Looking good. Slow and steady.
Volume pretty good as well.
Closing close to hod on a Friday is a good sign! IMO GLTU
Going to be interesting to see what happens last 30 mins of trading.
Nice green but somewhat sideways action. This is great for building a nice base here in the .02 area ahead of upcoming catalysts. Stock should move up to .025-.03 range on FDA resubmission news. And quite frankly, I would like to see it trade sideways while the FDA reviews. If and when FDA approval happens, .05-.10 is my initial target area for the spike on what I assume will be large volume. Then plan to hold a chunk for earnings forecasts and potential buyout from a bigger fish in the CPAP space.
ok thanks!!
https://twitter.com/RemsleepInc
Check out there Twitter account, company stated yesterday that they would be issuing a formal PR next week.
Have anybody some news about this stock?
I would appreciate it.
Nice little move up earlier this morning. I expect it to continue creeping up over the next several weeks. Should push above .02 area on news submitted back to FDA for decision.
One would think. They’re going to be out of excuses at this point, at least anything anyone will actually believe. This is really their last chance to prove they’re legit and this 501K is moving forward to a decision. The biggest update I’m waiting for is that everything has been submitted and the FDA is on the clock. That happens and I think you’ll see renewed interest, volume, etc.
What do they mean by "closer to having everything prepared for our submission"? I would thing as long as this has taken this should be the only thing left.
Bottom in with solid support here at .012 now. This will creep upwards over the next couple of weeks.
Yeah, I think that's pretty spot on. I do think this will see a bump up though once they get it back in front of the FDA, which could be anywhere 2-3 weeks IMO.
Yeah, then 30 days to hear back from FDA. Looking like 2 months until we get any news.
This is trading like the dilution has finally come to an end. Seems to be just light trading and purely retail. Should start to trend up heading into next week when the testing results are received. Then hopefully just a week or two tops to do one more final review before submitting to the FDA.
Fingers crossed the results are in line with what they expected (i.e. successful) and they can submit within a week or so after confirming everything is in order.
Remsleep Holdings Inc
@RemsleepInc
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6m
We anticipate getting test results back by the end of next week. Once we receive those results, we will be closer to having everything prepared for our submission. $RMSL
Decent close although I think the jury is still out on whether today's hammer is the turning point where this start moving back up. Will see how the rest of the week goes and see what if any updates come out from IR.
Yes, I did see that mentioned in a follow up tweet that they can use the extension. My hope is that the retest is really all that is needed since the post test analysis was based on it being done correctly, which after this should now be the case. They shouldn't have to redo everything like they did after doing the condensation testing, at least that is how I was looking at it. My hope is back in front of FDA by the end of this month, with late April early May as a final decision date.
Will see news that new test has been completed, then hopefully we get an idea how long before they submit to FDA. They are lucky that they have an extension so process will not restart from the very beginning.
Bought back in low .01s, will see how this plays out over the coming weeks. If they can get this back in front of the FDA, I think it should start trending up from there until a decision is eventually made.
Almost back in buying range. Gonna wait a few more days and see if it dumps down to .01 area.
It's always something, a while back didn't they need to redo a test for moisture. Same story different reason.
Remsleep just put a Tweet out. The discrepancy is procedural and relates to test conducted in early 2021. It appears procedures may have now changed so test being re done. Looks like nothing to do with most recent tests, just a change in how things are now done from previous test.
If that's true, we go sub penny tomorrow.
Re-testing is not done as a result of a "discrepancy". They got a negative result on a lab test that would result in rejection from the FDA and therefore:
Big difference between discrepancy and failure. The company would have to issue a PR if the trial had failed, and would have had to have done that within a few days of being told this.
Looks like to me it’s something minor but has to be dealt with before submission. I agree though it would be nice to know what exactly the discrepancy is.
So you are saying that despite issuing a press release in August 2017 that the DeltaWave was available for pre-order with delivery in November 2017 that they hadn't submitted the 510k application to the FDA until last year? Ok.
https://remsleep.com/remsleep-holdings-inc-launches-new-cpap-mask-designed-to-improve-sleep-apnea-patient-comfort-and-compliance/
False. You obviously haven't read their PRs or filings since 2015. They claimed they had filed the 510k and were waiting for FDA approval when they took over the RMSL shell from KAT Gold at the end of 2014.
They have been claiming it was forthcoming for years and then finally admitted it was rejected and resubmitted recently.
You can’t wait on FDA clearance until you actually submit your product for clearance. So that has been since last year. What you should be saying is waiting over 6 years for product submittal to fda then about 8 months waiting for fda clearance.
And now they are saying they need 3 more weeks haha. More like 3 more months. What a joke this company is.
Incompetent management, dilution, lack of follow up on the 501k application, empty promises, worthless investor relations...those are just a few of the things that come to mind.
Anyone know or understand why we continue going in the wrong direction here?
Load up, wait for the next one! This is a good stock to play over and over.
What a turd. This is what happens when you dangle the carrot for so long but fail to deliver on anything.
SEVEN years of waiting for the 510k clearance on their flagship product. Their 2015 8k stated they already HAD the patent on the DeltaWave and they've been claiming the 510k is imminent for SEVEN years.
Maybe you should change the name to Team Gaslighting.
Agreed. This Tz3sports just made some sort of farewell speech on Stocktwits. He should consider the same retirement in Ihub.
Yeah I can't put any stock in what someone says if their comment has to resort to name calling. Way to show your intelligence.
Agree, these constant delays to even file with the FDA are taking too long. I sold this week.
Hope, but now just tired of waiting and there always seems to be some kind of delay. I've had several other pinkies that kept having delays and you just sit there and watch the share count increase. I can always get back in.
You could have sold several times over all year. Why now?
If you read and understood my post I said I have been in over a year. There is no mention of any stock timeline.
The patent wasn’t received until April of last year… FDA 510k wasn’t started until mid year. So to say it’s been well over a year and to complain about the timeline makes no sense
I've been in this well over a year. Thinking of selling, at least my profits will be taxed as long term gains.
I agree - time to get this going!
Yadda, yadda, yadda, blah, blah, blah. Seems like we've heard this before.
That’s about what I figured. They need to pay off the remaining notes with the capital they just raised. They do that and keep the share structure tight moving forward, could do well in the coming months. Of course this assumes they finally resubmit to the FDA soon.
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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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