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FDA decision getting closer and closer. Can't be more than a couple weeks away at this point.
If you claim to have been doing it for years you know that the fda 510k has set time limits. There is no scenario that a 510k takes longer then a year without needing to be refilled
CEO didn't file a PMA until 2021 which is why it's been seven years with no cleared 510k and the company diluted into the ground.
He didn't disclose he was trying to pass off the 2008 510k from the Laminair modified as the DeltaWave when any fool could see they look nothing alike and no way in hell passable with the FDA.
PMA is a much more in depth process. Shortcut and non-disclosure cost folks a lot of time and money.
Looks like a knock-off of Resmed's Airfit P10. Not exactly revolutionary.
The fact that their patent was initially rejected tells you the patent office didn't think it was all that original.
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
Inventory of masks? First of this is a revolutionary design… second off the machines are the shortage not the masks…
Well actually the 510k cannot take several years. There is a well defined process and RMSL got an extension on the Additional Information request. Had there not been a lab error the AI response would have been submitted back to FDA in January and final approval would have been completed already.
They are at the point of pass or fail… if fail they will need to submit a new 510k application
a 510k submission can take multiple years, as many years as it needs to.
I heard from some other chats MMs will run this to .25-.50 running into FDA.
Whoever is forecasting that crap deserves to be ignored forever. This company has one mask they've been touting to sell stock for years and years, and even if the FDA were to approve it, it won't sell. One mask, all that anybody needs to do is look through the inventory of masks from real companies on CPAP.com or other online vendors to know that this has only been a stock sale.
Predictions: nice my 2 million shares will put me on a different level
Based on our forecasts, a long-term increase is expected, the "RMSL" stock price prognosis for 2027-05-21 is 65.732 USD. With a 5-year investment, the revenue is expected to be around +182489.44%. Your current $100 investment may be up to $182589.44 in 2027.
Idk how to make it more clear than physically copying and pasting the 8k information.
If you can't figure it out from there I can't help you.
You said they called a new company after they failed the second test, not the first which is NOT what was stated in the 8k.
Correct, I did say that and the 8k from March 31 says exactly that as well.
"Dr. Nieusma concluded that two previous tests conducted by a third-party laboratory were flawed in the calculations contained in the testing protocol resulting in the failure of the cytotoxicity tests. Changes to the protocol did not result in a successful second test. Accordingly, a different laboratory has been contacted by the Company and Superior to review the original tests. It is the conclusion of the latest third-party laboratory that the original testing procedures were significantly erroneous, leading to the failure of the tests."
To the moon next week. Are we loaded for .10$$$
No. You said they "called a new company" after they "did it wrong a second".
They hired a toxicologist AFTER they failed the FIRST test not the SECOND because they were blaming the "procedures".
The toxicologist changed the procedures and they STILL FAILED the retest.
And the toxicologist admits he had a "backup" lab if they didn't like the result.
LAB SHOPPING.
Lab shopping is going to be a problem.
They also tweeted another excuse that they were going to narrow down the specific part of the DeltaWave that they thought was causing the test failure.
So they blamed the "procedure", blamed the lab, and pointed to the device actually causing the failure.
Not exactly a vote of confidence. Not a great track record.
You just proved my entire point. Third test was the second company.
Thank you.
That's blatantly not true.
The same company that stuff it wrong the first time did it wrong a second.
THEN they called a new company and he said, yes, they messed up. And then proceeded to do it correctly with a successful result.
They blamed it on the "procedures" and specifically hired a toxicologist to change the procedures and they failed AGAIN.
They used the original company to test the first two. THEN changed companies.
Hahaha...they FLAT OUT FAILED TWO cytotoxicity tests. It's right there in RMSL's
OWN 8k. The toxicologist they hired to oversee the new "procedures",changed the "procedures" and still failed the re-test.:
https://www.otcmarkets.com/filing/html?id=15699670&guid=Q9KwkpikzTtrdth#ea157712ex99-1_remsleep_htm
So FDA 510K supposed to take ONE YEAR? Is that what you are saying?
30 day clearance last year? Where does anything say that empirical was supposed to get everything done in 30 days?
They were brought on last June to take care of the current 510k.
The failed cyto test from earlier in 21 wasn't actually a fail based on what was published. Filling says 2 failures but the failure was on not noticing the test was done improperly. It was passed but with incorrect procedures so it was missed on the initial submission. When found they addressed it with the same company who again did it incorrectly with a failed result. They went with a different company and passed with the correct procedure.
It's now back in the FDAs hands. They have less than 20 days for a response.
CREDIBILITY. TRUSTWORTHINESS. TRACK RECORD.
There is no way to sugar coat the fact that the CEO didn't disclose there was no new PMA 510k filed for the DeltaWave (for several YEARS) and instead he was trying to pass off an old 510k that he never disclosed until someone who actual does DD posted the discrepancy from an SEC offering which referenced the 2008 Laminair 510k on this board. Meanwhile telling shareholders everything was fine and dandy and sat on the information until he was boxed into a corner. SERIOUS OMISSION from a CEO because it most certainly would have impacted shareholders' decision to invest.
CEO also didn't disclose the failure of the cytoxicity test from A YEAR AGO until recently. Tried to pass it off as just "procedural" when their own contracted toxicologist says it flat out failed.
These are inconvenient details for the pump crew. Really hard to try to convince folks that the aforementioned "doesn't matter". Good Luck.
Decision should be out the week of June 6th. I think they do give themselves a 15 day grace period extension if they need it but I am hoping we see an early surprise maybe next week or that week of the 6th. Exciting times here!
It's a porker on a cliff now.
The past OS doesn’t mean anything for current SP moving forward…
There was a reg a offering and debt conversion in the past… offering was closed early the OS is why it is and the SP keeps going higher!
keep on inching up there little buddy
yea!!!!!!! wooooooooo!!!!!!! .10 will make daddy some money!!!
FOMO. Big FDA news coming next week per the last PR!!! .10
That's why it's a bloated hog now.
Why don't pumpers want their "Team" to have all the facts?
TRIPLING the O/S not on the bullet points at any time over the last year to the "Team".
????Team Tsunami????
Brief overview for those that are new.
-Audited financials since 2014, very rare for an OTC
-Open & transparent CEO
-Stated objective is to be ACQUIRED (RESMED has history of buyouts near 500 million)
-Management has over 40 yrs combined experience
-CEO has over 19 patents in the sleep apnea field
- DeltaWave’s unique patented design delivers 14 breaths/min, most others are around 9
-DeltaWave is the first mask that will treat patients with COPD & Congestive Heart Failure
Recent and future catalyst's
1. PR- CONDENSATION TESTS (1.5.22)?
2. PR- Investor Relations Firm Hired (1.24.22) ?
3. CPAP Distribution Agreement (3.22.22) ?
4. Completed/Successfully Passed Cytox Test (4.22.22) ?
5. CPAP Machine Update 33% increase in month two (4.27.22)?
6. PR- FDA AI Response (5.6.22)?
7. 510K APPROVAL (Est. June 6-16)
8. Uplisting to OTCQB - in Progress (PR Anyday)
9. Revenue/Profit Update Cpap Machine
9. Apply for CE mark for DeltaWave
I didn’t realize a ceo needed to explain to people how he is running the company… especially when his company’s stock has made share holders money.
In 16 months the stock price is up over 2000%….. remsleep was a pre revenue company so yes there was always going to be some dilution.
Not sure why you are complaining about the stock price continuing to grow.
The 510k process will be completed in under a month.
$50million marketcap and still NO FDA 510K
Not a word to the "Team" that this is what was happening to the company in the span of only one year.
Not ONE mention of convertible notes until they were mostly converted.
Since the date of your picture RMSL is up over 50%
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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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