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Now dropped to Pink Sheet Status.
http://www.otcmarkets.com/stock/NRTI/profile
That isn't an FDA approval date. That is the date the clinical trial is expected to be finished by those who are conducting the trial - therefore the date they expect to collect the final data.
My favorite part of that interview was when Andy said that "our's is clearly non-thermal" when talking about the FDA creating a category for SWT devices.
In the May 4, 2012 letter to shareholders, when talking about the FDA denial of Allay he stated, "The FDA reviewers mislabeled the technology as 'non-thermal diathermy.'" That was back when he spent months trying to make the argument that the devices should be considered as deep-heating b/c they increased the temp of human tissue up to 1 degree C.
According to the FDA:
I'm only aware of the 5+% requirement.
To be sure of investor filing requirements, you should contact your broker or see the SEC's investor help area.
There are issues with the accuracy of the substance of what you had quoted.
Currently marketed, unaltered SWT devices are considered prescription-only Class II devices. Refer to II. Public Comments in Response to the Proposed Order in the Final Order. However, the manufacturers are expected to file a 510(k) amendment to prove that they comply with the special controls listed in the Final Order by Oct 13, 2016. Failure to submit the amendment, or failure to prove that they comply with the special controls means that the manufacturer will lose the right to market the device. Refer to IV. Implementation Strategy of the Final Order. It appears that the FDA is willing to work with manufacturers if more time is needed.
Hence, it may not be a good idea to use a currently marketed device until it's proven that they fully comply with the requirements of the Final Order.
https://www.federalregister.gov/articles/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to
If the O/S is at a number where your 49M makes up 5+% ownership of common stock, and you haven't registered with the SEC, then yes. You have within 10 days of crossing the 5% threshold to file.
http://www.sec.gov/answers/sched13.htm
I don't know about the rest of what you posted, but I do think they have heard from the FDA about their application. IMO, Biel will either need to clarify data, or present additional data. FDA has been researching information regarding shortwave therapy for years now, so they are familiar with it and Biel's tech. I doubt they needed the full 90 days to review the application. In either case, a new 90 day review cycle will commence when Biel responds with the information requested.
From the filings and change in OTC Company profile, he appears to be attempting to do so. Like I've said several times, I'm not a fan of the idea for varying reasons which is why I'm sitting on the sidelines and keeping a passive eye on what's going on.
I wouldn't keep my hopes up.
This stock might have opportunities to flip, but no one knows when. IMO they are doing something behind the scenes, but I don't know if it will amount to anything positive in the news department.
Kuni is going into the world of mineral exploration. I've invested/traded in several. That can be expensive and time-consuming for a nano-cap stock like PIHN. If he's serious, I don't think he knows anything about the subject. A lot of work goes into mineral exploration, so a company better know what it's doing to minimize expenses. So he has to rely on his advisors. We don't know who those advisors are and how credible they are. As I pointed out in another post, there are red flags in the "Sineloa" location. IMO, there are many underlying problems here that need to be addressed.
I'm keeping a passive eye on this stock, but I'm only watching to see what unfolds.
GLTA
No.
The last 10-Q says the O/S is 852.3M as of 8/18. Also says the same number on the OTC Markets company profile.
IMO, probably north of 1B right now.
I just know from a reliable source that you could buy it via Amazon, and was shipped from somewhere in the midwest or east coast. I don't know if that doctor ran that site that was listed on Amazon. That device worked.
I was referring to the part of the letter that stated,
Those 8-K's should be posted to the OTC Markets or SEC website. They are not. I just checked.
That was part of the "concern" back in 2012. Investors were told in Aug of 2011 PR that, "We have supplied FDA with an extensive amount of information, which we believe more than adequately addresses their questions. As a result we are expecting a positive result from the application process over the coming weeks."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=65819216
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=65886720
There wasn't any filings or Shareholder Update to let investors know what happened. We didn't find out about the NSE from the FDA until weeks after the warning letter that was issued at the end of January 2012.
I somewhat remember the situation and conversations back then. I was looking for info on this board, Yahoo, and Google Finance boards.
In the fall of 2011 you could go onto Amazon.com and order it. It was shipped from within the US.
Which 8-K? There have been none since Feb 2011.
http://www.otcmarkets.com/stock/BIEL/filings
Investors found out about it from stockdarockk in Feb 2012.
The FDA stated in the letter they were able to buy the products off of the company's websites w/o a prescription. That prompted the warning letter.
There were also companies within the US that were distributing the product.
Charts and some common sense showed this was going to make a reversal.
10/12-10/13 period
After the large spike to .0025 and close at .0020, this was trading outside the upper BB which can be a sign of a reversal. Plus, the stochastics were also indicating a reversal was near.
http://stockcharts.com/h-sc/ui?s=BIEL&p=D&b=5&g=0&id=p89249295624
FDA already had the Final Order finished before the market ever knew about it and they've spent months going over the past clinical studies on this subject. If Biel satisfied everything to 100% of their liking back when they submitted the application in early Aug, IMO they would've been cleared by now. IMO, clearance will probably happen, I just don't think it will happen in the current 90 day review cycle.
I don't see the correlation between Biel and that stock.
The price for that stock dropped like a rock b/c they were on the verge of declaring bankruptcy. They had $5B in assets and hundreds of millions in quarterly revenue, but they were billions in debt and owed $175M of that debt that they couldn't pay at a particular deadline. They hired advisers to help them with the bankruptcy which helped accelerate a sell-off. It wasn't until a 3rd party came along and saved them that things turned around for that stock.
It starts on the day FDA receives the 510(k). If FDA changed any parts of the special controls between August 6 and October 13, Biel would still have to comply with those changes in order to gain clearance. That is the risk of submitting the application before a rule becomes final and effective.
Keep in mind, the 90 day review cycle is the goal, and it's not a hard date. FDA will usually contact the company within 90 days. The total length of the review period all depends on whether or not the FDA requests more information and how long it takes for companies to submit that additional info.
Depends on what the FDA decides.
No. The Final Rule has been published with an effective date, along with a date (1 yr from now) in which they will enforce companies with currently legally marketed SWT devices to comply with the special controls established.
http://www.reginfo.gov/public/reginfo/Regmap/index.jsp
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334766.htm
The only question for Biel now is whether or not they satisfy the FDA's requirements, in the eyes of the FDA (not the consumers/investors). Those special controls are listed in section 890.5290 Shortwave diathermy of the Final Rule.
https://www.federalregister.gov/articles/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to
You really need to look at the Company Profile on OTC Markets website (the company provides the update to the site). The O/S is no where near 160M.
SEC can suspend the trading of Pink Sheet stocks for 10 days if it has concerns with the information that a company has released publicly. They did it several times last year with startup marijuana stocks. That essentially kills the stock as the OTC will drop that suspended stock to Grey Market.
I don't blame you or anyone else hesitating to play this. Ken has burned many that have tried to hold this stock.
I had an order for 1's for a couple of days, but the MM's weren't budging. It's been trading tightly for the last 5 days, that's prompted me to move in on 2's for a relatively small position. Knowing my luck, it'll drop down to 1's tomorrow or Monday.
It's OK, I'm mostly playing with "free money" he gave me last week.
I picked up some 2's. What can I say, I'm a glutton for punishment and a gambler. :) They were tougher to get this week (so far). I'm just curious as to what Ken is going to announce in the coming weeks.
As I've said with other OTC stocks, it isn't wise to invest in them, only to trade them unless they have substantial revenue and cash on hand. Definitely trade KATX at your own risk.
He's not bashing. He's just informed. Look up the 8-k that was filed back in May of this year.
The stock is trading at 3/100 of a penny, not at 3/10,000 of a penny as originally stated. It is trading 3/10,000 of a dollar.
I see they pumped it as a weed/hemp stock.
Late filing it is.
We can go 'round and 'round in circles b/c you are only trying to address one part of what was said, while avoiding my questions for you.
We will revisit this in a few months.
Who said this?
How else do they meet the requirements by Nov/December? This is trading at .0003 right now. You are hoping this spikes back to .01, that is unlikely.
We can revisit this conversation in a few months.
Typically it's easier for a company to obtain financing on a better exchange other than the Pink Sheets.
Not sure why they would make the effort to gain OTCQB status early this year (March), only to be dropped off of it later in the same year.
Their revenue has dropped for various reasons. They had inventory that was about to expire.
They would need a major announcement to spike the PPS near .01 temporarily, let alone hold it there 10 consecutive trading days.
Your efforts to pump this stock are not including the proper reasoning.
Depends on when they received the notification from OTC that they did not meet the standards. From that point, they can be granted 6 months grace period to meet the standards for a period of time. Refer to Section 2.3.2 of "OTCQB Standards" in the link I provided. They dropped below .01 back in late April. That should mean they have until late November or early December to comply. Since they have to be above .01 for 10 consecutive trading days to comply, that means they will have to vote (majority shareholders needed), approve, and execute before that time.
If they want to stay on OTCQB, they will have to R/S (soon). OTCQB has a min .01 price requirement.
http://www.otcmarkets.com/services/companies/otcqb/requirements
He has til Monday to file the annual report (90 days from 6/30) or a notification of late filing.
Now, I can't find Sineloa, Mexico on a map...
I've been looking at the charts. I also know the history.
Still, the volume is very high considering the O/S (>50%). If there was a lot of buying pressure, IMO it should've broken past the resistance at .0004 already. Hell, should've seen 5's already on the ask (IMO). Like I said, still got time left in the trading day.
320+M so far and this thing is still at .0003 - not encouraging sign. Last calculated O/S was around 590M. Still about 3 hours left in the day, and I'm curious to see how this plays out today and tomorrow.