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The first 510k was rejected. The second 510k will most certainly be rejected if they can't pass the cytotoxicity test. They can't continue to pass the blame forever.
Has not been rejected, they have an extension to complete this test. Let’s see what happens, they say they know why this happened and must have been fixed as they are conducting another test with results in a few weeks. Time will tell.
That would be believable if they passed the retest. They were in control of the "procedures" in the second go round and still failed. You have to be in serious denial that there appears to be something critically flawed with the safety of this device after being rejected by the FDA after waiting six years on the first application and now a twice failed cytotoxicity test a year and a half later.
At some point folks need to face reality regarding the incessant BS coming from this company.
That’s not correct, the original issue was a change in procedure for the actual test, it actually passed but FDA changed procedure for this test when they came to filing.
It does look like it failed new test, but appears to be a minor issue which they have identified, new test being conducted with results is a few weeks, so we will see.
No money in re-selling third party products from China that are a dime a dozen.
Typical red herring from Tom to take the heat off. He diluted the company into oblivion and now has the cash from the latest offering to sign a lease on a warehouse and buy a few machines from "overseas" aka China to give the appearance the company is doing something.
The ONLY thing of value is the 510k clearance for the DeltaWave. Failing a critical "cytotoxicity test" twice is the death knell for RMSL.
Yes but they just leased a new 10000 sq ft building for future CPAP sales . So what next?
And there you have it...not only failed the first cytotoxicity test, but failed the retest.
Nice touch in the PR that Tom says there have been no issues other than a "failed cytotoxicity test"...the crux of the safety of the device and the clearance/denial of the 510k.
https://www.globenewswire.com/news-release/2022/03/28/2411010/0/en/RemSleep-Holdings-Inc-Provides-a-Shareholder-Update.html
They're terrible at shareholder communication. Even with the new IR, she is pretty clueless and it sounds like Tom keeps her in the dark like the rest of us. Last we heard was that the testing was supposed to be wrapped up and results were to be provided a week ago. Did that happen? Who knows. Is it possible they did get those back and are now heads down reviewing everything and making sure the application is ready to go? Possibly. Would be great if they announced next week that it was back with the FDA for review. That would really generate some excitement and finally put this on a countdown.
Anyone else confused about what the heck is going on with RemSleep? Did they submit to the FDA or what??
I mean it's hard to argue with you because that's how I am looking at this now too. They tweeted about having the testing results completed and results in hand by the end of last week. Today? Nothing. No tweet on whether that happened or if they ran into more delays. The fact they aren't responding to emails on it doesn't look good either. They need to address this or this will fall down to .01s again.
Fluff PRs from Tom = FDA delays.
Always some generic BS to distract from the only thing that matters which is the 510k clearance.
They rolled out a website claiming to sell third party CPAP machines and products years ago and have ZERO revenues to show for it. Anyone can buy these products cheaper elsewhere online.
The only unique product they potentially have is the DeltaWave. Without the 510k clearance this company has nothing.
Yeah, I know. I am here for the FDA approval though, and it's been dragging since late last year of just getting this back into the FDA's court. Here we are in late March and still no definitive word on whether they have everything ready to submit or not. Just gets frustrating dealing with this company because they put these self imposed timelines out there and then never execute to them.
I feel your frustration. The entire OTC market this year has been a real killer. Just trying to stay positive. There has been some movement of some OTC stocks as of late. Hoping things are just starting to kick off instead of just getting skipped over this year. GLTU $RMSL
It's not with the FDA yet. That is what is bugging me about the news today. It's these periods where they say something will happen (e.g. testing results would be provided back last week) and then they just go dark until it's finally at a point where the concede a setback. Seen it too many times here and hoping this isn't going to happen again. I can't stomach another move to the .011 support area.
The news today should be pretty strong evidence they are extremely confident things are going to be approved very soon....GLTA
Yeah, but now they’re being quiet again on the testing and where things stand there. Hope it’s not another setback at this point but sorta surprised they haven’t followed up on last tweet about it saying results would be provided at the end of last week.
The United States has been experiencing a major shortage of availability for CPAP machines. This occurrence has been due to a recent recall from a well-known manufacturer, as well as global supply disruption and congestion, leaving many suffering from sleep apnea, quite alarmed.
RemSleep Holdings Inc. hopes to address this by providing CPAP devices to alleviate the ongoing shortage. To accommodate for the expected growth, the company has entered into a three-year lease to relocate to a 10,000 square foot office warehouse in Largo, Florida. The company is also looking to grow its staff as well as engage in a strong marketing campaign and website revamp for its product.
“These are exciting times for our company! According to online studies, 50 to 70 million adults in the United States have a sleep disorder and an estimated 22 million Americans are living with moderate to severe sleep apnea. With the current shortage of CPAP devices, the quality of sleep for so many individuals are being affected. We believe we can aide in addressing this by supplying nasal devices with our new agreement, and make our product easy to access and affordable,” said CEO Tom Wood.
Unexpected news today.
Tampa, FL, March 22, 2022 — McapMediaWire — RemSleep Holdings Inc (OTC PINK: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients, is excited to announce that the company has recently negotiated an agreement with an overseas manufacturer for the import of nasal CPAP machines.
The initial order of 1500 units has been placed and the shipment of nasal CPAP devices will be expected to occur in mid-April, with a large quantity of additional units being delivered in the months to follow. RemSleep Holdings Inc. is anticipating preselling the total units, prior to their arrival. This will directly bring positive sales and revenues to the company.
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
·
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.
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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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