Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Here is the SEC investor information bulletin on suspended stocks.
https://www.sec.gov/investor/alerts/tradingsuspensions.pdf
There are forums on IHUB dedicated to suspended stocks and stocks that are on the Grey Market.
Which penny stock do you think they are referring to? Is there one that is not named in the filing that we all should know about that is directly related to the situation?
You can try to spin this however you want, for whatever reasons you may have. BIEL, being controlled by Andrew Whelan, is in the middle of all of this. Hence, shareholders are caught up in the middle of all of this.
You should read it again, starting with III on page 10 - specifically paragraph 46. Penny stock suspension is on the table. As it has been said before, if the SEC suspends a penny stock, it eventually heads to the Grey Market which is bad news for investors.
If a pink sheet stock gets suspended by the SEC, it heads to the Grey Market. Shareholders would have to contact their broker on their options at that point. Stocks still trade there, but it's not a good situation at all.
I think gagged TAs varies from stock to stock.
Early last year, I was able to get an updated O/S from the TA of a pink sheet I held.
The TA of a (former) OTCQB stock I own was gagged.
Michael is on the Board of Directors at American Eagle Outfitters and XPO Logistics, Inc.
To be brief b/c I'm not interested in getting deep into the daily debates on this board:
I think Actipatch could eventually make its way to OTC.
I'm not a fan of investing in the stock. It is tradable.
Do you mean when I responded to you a few days ago when you asked when they would file 4Q15?
There are 2 basic timeframes you need to know for the filing of financials according to OTC Markets guidelines (can be found on the website):
1) {10-Q} within 45 calendar days after the end of each quarter (1QYY-3QYY)
2) {10-K} within 90 calendar days after the end of the fiscal year for the annual report (end of Biel's fiscal year is 12/31)
Biel's annual report for 2015 is due at the end of March. Refer to their previous filings for more information.
A lot will depend on whether or not Ken finally PRs the milestone news he talked about in September, and what that news is. If it's just another used car dealership, then I wouldn't expect much. If he announces something with Hodderville, as mentioned in that pump piece, then that may be more significant.
http://finance.yahoo.com/news/kat-exploration-inc-purchases-pre-152700772.html
That's because they are required to file quarterly reports within 45 days after the end of quarters. Biel has waited until the end of March to file the last couple of years. They've waited until early April or longer before that.
According to OTC Market guidelines, they have 90 days from the end of their fiscal 4th quarter (12/31) to file the annual report.
According to their statement on transparency, Shire is supposed to release the results to the public within 1 year of study completion.
DEA already made that request to FDA.
http://www.bloomberg.com/news/articles/2014-06-20/drug-regulators-study-easing-u-s-marijuana-restrictions
FDA was reviewing data which may take awhile, depending on the quality of the clinical studies in the eyes of FDA. The fact FDA was reviewing data was stated in a 3/2015 PowerPoint presentation link (page 18).
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM438966.pdf
There is debate about how far along the process DEA is with respect to the rescheduling evaluation.
Here is a more detailed chart with FDA's role in the scheduling process from FDA's website:
http://imgbox.com/Jy01luBd
FDA advises the DEA and can recommend that marijuana is rescheduled with data and scientific research. FDA is currently involved with research in the area. DEA can initiate the federal rulemaking proceedings to reschedule. The administrative process is more complicated than the legislative process and can take MUCH longer to do. Rulemaking process involves data gathering, private and public meetings, evaluation of comments from public as well as all data, etc. I just watched one process take several years to finalize. In a nutshell, FDA changed a classification of a medical device to a less restricted class.
Here is an explanation from the Brookings Institute with a flow chart.
http://www.brookings.edu/blogs/fixgov/posts/2015/02/13-how-to-reschedule-marijuana-hudak-wallack
Rulemaking process
http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf
They've done it at the end of March over the last couple of years. Under OTC Market guidelines, they have 90 days from the end of the 4th quarter (12/31) to file the annual report.
I see that Shire is still posting filings with the SEC over the Baxalta deal. Hopefully once the dust settles on that deal, then they will focus on their existing trials. The status of SHP622 on their clinical trials site is still a mystery.
ILNS PPS isn't moving without significant clinical/FDA-related news, notable insider transactions (ie. a major investor), or something that can create a better idea on the value of the stock. Gotta give the investment community a credible reason to buy and possibly hold the stock at .10, ,20, .30, etc. Hopefully, that comes soon.
You said it's not verified.
The site, that was developed by the NLM and NIH with the assistance of the FDA. The sponsor or principle investigator of the trials update the information. It's not just some bulletin board. As the quote said, it was set up by the Food and Drug Administration Modernization Act of 1997, which was signed by President Clinton.
That is not accurate at all. You may want to read the information about the Clinical Trials website.
TA is gagged. They cannot comment on the current share structure to shareholders or to the public.
Only way someone is going to find out what is going on is:
a) NRTI finally releases something
b) an entity within the federal government reveals something
c) shareholder(s) hire a good attorney that can invoke shareholder inspection demands based upon the events that have occurred over the last year.
I didn't listen to the presentation, but I did look over the powerpoint presentation.
Good news is that SHP622 was officially still listed as rare disease program for FA as of 3Q15.
Bad news is that I didn't see anything else regarding SHP622. There were no other notes like some of the other programs.
Screencap (click on the picture to enlarge): http://imgbox.com/2U7cknem
Big companies (esp publicly-traded ones) aren't afraid to spend, but they don't just throw money out there blindly. They have bottom lines to meet (for investors). I used to be a part of one and they constantly reminded us of that fact.
It's cool if you are one of his 118 followers, a visitor to this board, or you regularly shop at that store and are looking for the product.
My problem is that their competitors have been using social media MUCH MORE effectively than them. It's very pathetic that their Vitamin Whey IG page has 6 followers and their Surgex IG page has 58 followers and is used as a fantasy sports promotion page. At least Bikini Ready has 4,838 followers. Just imagine if they posted that promo to thousands of followers on their Vitamin Whey IG page. Think about this: Chelsiearyn (the girl who won their contest years ago) has 112,000 followers on IG and she has ~37,900 followers on Twitter. They opted not to use her before she became a playmate. She had interest in working with them (I mentioned it to her before she became a playmate). She would have been great for Bikini Ready, and could've been obtained in addition to Anastasia Ashley for a longer period of time and for less money. All they needed to do was send her some of the product with some cash, and have her take selfies with the product and post the pictures to her followers with Bikini Ready and Inergetics tagged. Inergetics can then repost the images on their pages. That is what their competition does with their models.
I do think that Shire has decided on a path. IMO, they have been working out the plan for that path. No updates to their trials site yet.
http://www.shiretrials.com/en/studies
I think it would be hard for both sides to fully discuss and finalize any possible buyout of Intellect until more clinical data is gathered from Phase I human trials of TauC3. We know the value of the SHP-622 deal, so we can assume a minimum bid, but not a fair bid to both sides if you add in the value of TauC3 which could be significant if the human data supports rare disease treatment. I don't know that Shire wants to start making a bid without knowing more, such as the safety and efficacy in humans. IMO, Maza may be confident that sufficient data can be acquired within the next 3 years, which is why he structured his deal that way.
I'm imagining that Shire proceeds with phase II of SHP-622, pays a milestone along the way, and Intellect uses that money to fund TauC3 trials as planned earlier last year. From there, who knows.
I see Kras is promoting Vitamin Whey.
I hope the BOGO for Vitamin Whey is part of a promotional thing and not a bad sign.
https://meijer.shoplocal.com/MeijerSneakPeek/ListingDetail?ispartial=N&ReturnCircularPageFlag=Y&SneakPeek=Y&StoreID=2465821&ListingID=-2032315876
For ILX and IMJ devices between 2010 and 2014, no.
-Out of 6 devices-
Longest: 697 days
Shortest: 169 days
http://www.emergogroup.com/resources/united-states/fda-510k-calculator
He's waiting on Shire's decision, but for the short term he's not waiting for a buyout offer.
I'm surprised that more aren't freaking out about the Chapter 11 they just filed.
http://www.bizjournals.com/sanfrancisco/blog/biotech/2015/12/martin-shkreli-kalobios-kbio-bankruptcy-chapter-11.html
It's not only about the data though. It also has to do with the design of the clinical studies and the methods used for treatment, pain measurement, etc. Those factors in addition to the data for efficacy will play into the speed and favorability of the decision.
It doesn't seem that the FDA is overly concerned about the safety of SWT devices. They stated several times that the special controls will cover this area. They even shot down cancer concerns in the Final Order b/c there is nothing to support those concerns for SWT devices. Only way things change is if there is a significant adverse event with a SWT device.
The 2013 Executive Summary provided a good insight into what they are looking for with respect to clinical trials.
The CDRH has been reviewing SWD/SWT technology for the past few years to conduct an advisory meeting and to create the proposed and final rules. They should be very familiar with concepts so the delays should not be as long as they were prior to the advisory meeting.
He would have to wait for over 30 days to pick them back up, otherwise it's a wash sale. In that time, he'd have to pray that nothing is announced.
Not sure what this means, but
http://www.shiretrials.com/sitecore/content/studies/clinicaltrialsen/2014/11/19/10/58/shp-622-100?sc_lang=en
is down as of right now. Maybe they are updating the page?
Anyone have another link on Shire's Trials site?
http://www.shiretrials.com/
I can access other studies on their site, so it isn't some type of standard maintenance issue.
No update on:
https://clinicaltrials.gov/ct2/show/NCT01898884?term=20629-100&rank=1
You reduced a number on one side of a comparison by 100,000 and didn't do the same to the other side of the comparison just to try to make things work towards your argument.
That deserves a...
Deceased mathematicians are rolling over in their graves.
From a mathematical POV in such a comparison, the correct way to do it is to reduce both sides by a factor of 100,000 to make the comparison even. So it should be: 150,000 for Biel vs. 50,000 for Apple (approximation of course). By the same comparison, Apple would be worth $10.6M/share compared to $100/share for Biel. That is as far down the rabbit hole as I'm going for now.
Thanks for the link.
They have 25 projects, so they may not offer much information about SHP-622. I can see them providing info on their phase 3 projects listed in the slideshow, esp the resubmission of OPUS-3 to FDA.
They laid out the highlights of their pipeline on their 2014 R&D day a year ago.
http://investors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/year-2014/shire-randd-day-full-deck-final-121014.pdf
If we don't hear anything by early Feb, then the Q&A section of the financials conference call in mid-Feb may be the best way to find out when we may hear about SHP-622.
I'll call BS on that too. When I first started in FDA-related stocks, I tried to contact the FDA several times regarding similar information. They tell you that they won't disclose such information and that you should contact the company.
Is there a list of the most toxic financiers in the OTC world? I know that many point to Magna. A list may be a useful asset for investors when reading SEC filings and looking for signs of heavy dilution possibilities.
Are you still watching KATX and have you heard anything? They're supposed to release news tied to milestones sometime soon. Been very quiet the last 2 months.
Yeah, they had until the end of Nov or early December to get back above .01, not an issue now.
If they want to get back onto OTCQB, it looks like they have some hurdles to clear.
I think they will eventually do a R/S, just doesn't have to be in the immediate future.
Access to various forms of financing from accredited investors is the concern when it comes to Pink Sheets vs. OTCQB.