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You're welcome.
I think one issue may be that Shire is more focused on the Baxalta deal and their later stage programs that will generate them money in the near future. In one of the presentations I recall seeing a director say that they were looking to prioritize their programs. They can still conduct normal operations with their other programs, but the final green light to proceed may be forced to wait. Good thing about dealing with major pharma is the deep pockets. Bad thing is doing things on their schedule.
The recent activity has me very curious.
Shire IR said that they are still looking at the SHP622 data to determine the future - so nothing new or any time frame.
NITE has been sitting at .10 for the last few days, when I've been paying attention. That never gives me a good feeling.
Gotta love the MM's.
Bid x Ask= .07 x .09 and the price was executed at .10 instead.
FDA's goal for a decision is 90 days after submission. Can take longer than that sometimes.
They keep a database:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/
My thoughts exactly about the focus.
I pointed out the patent Shire filed years ago mainly b/c those doctors are still with the company, unless they didn't update their LinkedIn profiles. They have detailed knowledge of Friedreich's Ataxia from their own research. Just points more to the belief that if Shire wanted to pull the plug awhile ago, they should've announced it by now. That's unless they moved that program to the back-burner for awhile. I think in one of the presentations, a Shire director mentioned prioritizing their programs. That is a negative about them hoarding such a large portfolio.
I'll admit, I could be completely full of s###, but there are several signs pointing to a more interesting situation developing.
For speculation purposes, and since we are waiting for something positive, I wonder if Shire helped restart the CONJUMAB-A program. Perhaps the Lonza agreement fell through.
Page 11 of the Shire annual report made me think about this more:
http://investors.shire.com/~/media/Files/S/Shire-IR/annual-report-2015/shire-annual-report-2015.pdf
Shire has invested over half a billion dollars in the last few years in their ophthalmology pipeline (via 4 buyouts). I could see them having interest in CONJUMAB-A with sufficient clinical data.
http://www.eyeworld.org/supplements/EW-Shire-Feb-2016.pdf
The fact that Shire boasts an Ophthalmics team with 100+ years of experience, and an internal R&D team, makes me believe that the hiring of Freilich signals ILNS will be in the drivers seat in the near future.
I can see Shire looking at a milestone payment for SHP622 as an investment into ILNS's other programs. Since Shire appears to be hoarding so many programs in their pipeline, perhaps they want some exclusivity there. This is where I wonder if Maza was trying to create any new deals or rework the old one with ViroPharma if it mutually benefits both Shire and ILNS. I do wonder if Shire would make a nice proposal for the rights to SHP622 if the data is impressive enough.
While I think a all-out buyout is a strong possibility in the long term since a lot of what ILNS has in its pipeline aligns with Shire's interests, in the short term I'm still very skeptical. I can see Shire trying to low-ball ILNS, and Maza not really going for any initial offers until he has better leverage with additional solid data for his pipeline. Like I said before, I'd LOVE to be wrong for the right deal. Hopefully we hear something very soon.
It appears Shire's had interest in Friedreich's Ataxia for awhile now.
Yeah, I came across her LinkedIn profile and saw she moved on. I just assumed that once Shire had the data, they let her go.
I think they just changed their IR contacts. I tried to contact one guy last week, and he's no longer listed on the page. I got an automated response that he was out of the office until this week. I just contacting the head of IR, so hopefully that person responds. I might try to call this week.
I think Shire is trying to work something out. With 60 programs, I think they are trying to minimize spending whenever they can.
I can believe that. I tried to contact them last week and didn't hear a peep.
I'm in the camp that believes if Shire didn't want to continue, they would've made it known by now. As of Dec 2015, SHP622 was still listed on their slate for FA (financials and main website). However, it's still not listed on their clinical trials summary site. No updates on the main clinical trials site either.
Might be a case where big corporate red tape is an issue. Shire now has 60 development programs in their pipeline. They're a big company, but that is still a lot to have to manage.
Can you cut your neighbors' yards too for extra luck? :)
Are you serious?
If there isn't substantial dilution (significant to O/S), then charts can be helpful. With the right FDA-related news, this can move. I'm seeing some groups watch this stock on social media and other IHUB boards. Ideal catalysts would be moving forward with Ph2 for SHP622, ODD, and a milestone payment. I still don't see a substantial buyout (yet), but I would love to be wrong in this case.
In the world of nano/micro-cap stocks, esp FDA-related ones, it's a waiting game. That is why they usually make poor investments and better trades in their early stages.
FWIW, the daily and weekly charts look interesting. Signs point to a possible reversal in the near term. It is the OTC world and anything can happen, good or bad.
Daily
http://stockcharts.com/h-sc/ui?s=ILNS&p=D&b=5&g=0&id=p65663959382
Weekly
http://stockcharts.com/h-sc/ui?s=ILNS&p=W&yr=1&mn=0&dy=0&id=p33906773620
As I said before, there are signs that something positive may be brewing in the near term. Hopefully we find out very soon.
I believe you.
Typically FDA doesn't respond to information about specific applications that haven't had information released publicly. They tell you to contact the company.
Market is waiting for FDA-related news. A significant milestone payment and moving forward with their pipeline will draw interest. How much remains to be seen. Investors like strong cash positions, relatively low debt, low share structure, positive clinical data, and partnerships with big pharma.
IMO, signs point toward some type of influx of funding.
Resuming CONJUMAB program, as well as others being at various stages of development, plus insiders increasing their positions are (usually) a good sign.
I'm keeping my fingers and toes crossed that we get an announcement very soon.
Website has been updated with info (FWIW).
As of 3/25/16:
O/S=2,505,624,900
Float=1,599,586,500
A/S=10,000,000,000
http://www.polaris-int.com/
That article is a bit biased. My mind kinda started to wander when it got deeper into the conspiracy theories.
As I said before, FDA should've come out and stated that CBDs will be treated as drugs rather than placing a muddled message when the MJ craze was at its peak a couple of years ago. IMO, the main issue is the dosage. At low doses, CBD may be OK. With higher dosages for longer periods of time, plus interaction with other drugs, things may change. That is why clinical trials are needed.
Not sure how FDA tries to monopolize drugs for big pharma. Smaller companies are key parts of the engines of discovery for new drugs and medical devices. Is it a perfect system? Definitely not.
My favorite line was, "The FDA is anti science and anti human rights".
In any case, Inergetics apparently dropped its CBD line.
They more than likely did a deep investigation into the company's transactions as a result of a credible tip or finding from another investigation b/c of the nature of the complaint. SEC isn't closely monitoring the thousands of publicly-traded companies at all times. They don't have the manpower.
How do you know these other devices may conflict with the patent? Do you have access to the design specifications of these other devices to verify that they conflict with the patents? There are various ways to design PEMF devices.
REF: http://patents.justia.com/assignee/bioelectronics-corp
If you do have knowledge of patent violations, then perhaps you should contact Andy and let him know.
I've rolled my eyes at that narrative more than once.
I'm well aware of that situation.
How do you know that only BIEL submitted a 510(k)? The two companies I referenced are private companies.
With respect to its power source, power level plus waveform, possibly not. I haven't poured through the internet to seek out every manufacturer of PEMF devices to study their devices. Closest thing I've seen was the device from Ivivi. Having not seen BIEL's patent, and Ivivi's design, I don't know if Ivivi violated the patent.
I do know that there is a portable PEMF device that is FDA-cleared for the treatment of knee pain. It was also featured in the Dr. Oz special, that is how I found out about it.
As of December 2013, there is a FDA-cleared, portable PEMF device that is used to treat migraines. As I've already posted, FDA even announced it as an alternative treatment for migraines w/ respect to a certain condition. They described the clinical evidence to support the clearance.
Good question that Andy would have to answer.
FDA doesn't comment on specific cases until that company decides to break the law.
It's not that I believe the FDA is "gold". It's that I don't have a ton of faith in BIEL making an effective argument before a governing body under today's regulation standards. As it's been pointed out, other PEMF device manufacturers have made an effective argument and received clearance in all these years that BIEL has been waiting. So FDA isn't opposed to the the method of treatment.
I've witnessed the history with this company and their hesitance to update shareholders with pertinent information either on their website's FDA chart, communication in emails (I've emailed Paul in late 2011 about the topic), or in PRs/newsletters. As fuente has said, shareholders had to find the information before the company said something. That tends to happen in the world of Pink Sheets since the standards are relaxed. I've seen BIEL try to make the argument that their devices are deep-heating thermal devices and that FDA was wrong to say that they aren't. Then, Andy turns around and agrees with the FDA when final order states the devices are non-thermal.
From other companies I've seen deal with FDA, I also know that (sometimes) there is more to the story than what is perceived on the surface. Those companies (some major and some microcap) have shared the correspondence since they are SEC-reporting companies. At times there are issues with the data presented by the company, or the design of the studies. Some issues with the study designs from various SWT companies were mentioned in the reclassification meeting. Until someone gets ahold of the communication that FDA is having with BIEL, no outsiders will know the issues FDA may be having with BIEL's submission.
If BIEL is confident that they are right, and FDA is wrong, then perhaps they should push for a CDRH advisory committee meeting.
http://www.fda.gov/AdvisoryCommittees/ucm414515.htm
FDA has even announced approval of certain PEMF tech (relieve migraine headache pain) in addition to the warnings associated with the device. It's not like they don't approve of the concept behind PEMF tech.
Streets are watching and waiting for bullish confirmation before jumping in.
http://runstocks.com/2016/03/09/under-0-10-momentum-play-intellect-neurosciences-inc-otcqbilns/
It doesn't look like it's a paid pump piece. I don't see a disclaimer that they were compensated for the analysis.
I've seen some people note the stock on some of the other IHUB boards.
I liked the fact that insiders increased their positions last month, and the recent volume and buying pressure may mean something positive is coming (IMO).
It's not about willing to do something. If it is proven that they violated securities laws, they will have to do whatever is ordered from the admin proceedings. IMO Andy is not going to want to do what the SEC wants to do without some type of fight.
It doesn't matter if Andy and Co. intentionally did something wrong or not. It is their job to make sure that at least one person involved in the transactions knows and to comply with all aspects of the law. This is especially the case since they were essentially given a slap on the wrist with Maryland. It's not a coincidence that the SEC included that fact in their claim. It was to point out that they were given a slap on the wrist before and they still failed to comply with some aspect of the law. The SEC is looking to send a stronger message to all involved in this matter since the 1st message from Maryland was not well-received.
I don't know if the fallout will be anywhere as extreme as stock implies, but I doubt they will get another slap on the wrist if the SEC gets their way.
Not that I'm supporting what stock writes, but I don't know that the SEC frequently loses. With admin proceedings, the SEC had a success rate near 90%. In Federal court it was closer to 69%. That is part of the controversy behind the admin proceedings.
As it has been said by many others, late filings wasn't the issue that led to a suspension since they are not a company that has to file with the SEC.
What you need to know about SEC suspensions is answered by Brenda Hamilton, a securities lawyer:
https://www.securitieslawyer101.com/2014/sec-trading-suspensions-101/
I noticed no real substantial update with Shire's 10-K filing. Just finally stated that the SHP622 trial was completed, instead of "ongoing" as they stated in their 3Q15 (and previous) financials. Still listed as Phase 1b for treatment of FA in global market as of Dec 31, 2015.
See pages 18 & 22.
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0000950103-16-011313.txt&FilePath=\2016\02\23\&CoName=SHIRE+PLC&FormType=10-K&RcvdDate=2%2F23%2F2016&pdf=
Since Inergetics was a SEC reporting company (I don't see any filings to state otherwise), I'm more worried about the stock getting suspended/revoked by the SEC which is very bad news for all investors.
https://www.sec.gov/investor/alerts/ib_delinquent_filers.htm
About Administrative Law Judge Cameron Elliot
http://www.reuters.com/article/us-sec-china-elliot-idUSBREA1107P20140202
I believe so. I've seen that with another company with private investors. They are contractually restricted to not exceed 9.99% ownership of the O/S. 10% ownership means affiliate status.
If some of you doubt that the SEC suspension is serious for current shareholders, and that it won't be moved to the Grey Market, then you should contact your broker(s) and ask them what they think. Be sure to talk to someone with experience in the area.
Maybe it was Collier's that was taken off the pull-down menu in addition to the New Mexico properties (Hancock and Red Hill) since it was in the 2015 business plan. TBH, I was mainly focusing on Hodderville the past few weeks.
I think revenue includes service and maintenance in addition to sales. I'm not sure how many repairs these used Jeeps need. For all we know they could be heaps of crap in need of constant repairs, but I've seen the store receive good reviews. I wouldn't get a Jeep.
FYI: website appears to have been updated.
I'm not sure if it is still being updated or not.
As of right now, only 3 Properties are listed in the pull-down menu:
Rusty Ridge
Deer Harbour
Hodderville
I think Handcamp and the 2 New Mexico properties were removed from the pull-down menu.
Clicking on the Properties link takes you to a "Featured" page that doesn't appear to be updated. It still has BVIG and doesn't list Hodderville.
Like I said back in September, I'm a gambler. My gut says that Stead is going to release a PR soon.