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The treatment appears to be twofold. Orthocor was seeking substantial equivalence to Ivivi's device with respect to parameters, treatment, and power when they were cleared (ILX product code). Key is the stated mechanism of action for the prescription clearance. Orthocor's device generates 6-7 microwatts per cubic centimeter of energy to the skin's surface. By comparison, ActiPatch delivers up to 7.3 microwatts per cubic centimeter. Both have similar types of batteries used. The pods themselves provide the heat as a supplemental form of treatment. They are Class I devices (IMD product code). The warning labeling (mostly) appeases the latter form of treatment.
https://www.accessdata.fda.gov/cdrh_docs/pdf9/K092044.pdf
As I stated as one of my points, Ivivi Torino devices appear to be the closer comparison to ActiPatch. They appear to rely solely on the electromagnetic field.
Basic overall point is that FDA is open to PEMF tech being used in the US, just need to prove efficacy at the indicated power levels in addition to satisfying safety concerns with the special controls. FDA stated it in the Executive Summary. The safety issues presented by FDA in the original order are not an issue with SWT devices. There are claims by some on this board that FDA is opposed to alternate forms of pain treatment with respect to opioids. That's really not the case.
Thanks, it's pretty much deja vu on this board. Whether or not to spend any money on this stock is solely up to the individual. If folks want to debate the valuation, by all means do so as it's their right. I'm just amazed by some of the claims. End of the day it makes no difference to me b/c as of right now I have no desire to throw money into this stock any time soon.
I'm just curious to see how this whole thing unfolds with FDA (and now the SEC). I invested some time years ago to help get SWT devices designated as Class II as I felt that low-powered devices did not warrant the precautions cited by FDA. Plus, I made a prediction last fall when people on this board were touting that FDA OTC clearance was coming before the end of the year. I thought they could eventually get clearance, but it wouldn't happen during that review cycle as I believe FDA wanted more data. SEC penalty may throw a wrench into all of that depending on what is decided by the judge.
4 things here:
a- Their knee device also seems to be higher-powered which can affect the amount of energy needed over a period of time for the desired results. They state that the device automatically shuts off after 2 hours of treatment. After initially buying the device, you can also buy refill treatment pods separately.
b-Device is also covered by private insurers and qualifies for HSA.
c-If the device is non-thermal, then it would fall under the SWT category. SWT devices are not OTC yet. Like BIEL with respect to treatment of edema following Blepharoplasty, they have to provide supplemental special controls information to FDA to maintain compliance as Class II device for general body use.
d-Ivivi's Torino devices are(were) similar to ActiPatch. The device manufacturer built 50,000 of the 2 versions of the Torino devices. Not sure when they last updated those numbers.
I remember seeing that claim awhile back. I'd like to see an example of such a stock esp with a similar share structure.
If they were to receive FDA clearance, IMO there would a spike and substantial profits could be made depending on how much one has put into this stock and the average entry point.
Having said that, it just wouldn't be anywhere near some of the claims. I see people have made the hypothetical comparison of market caps between BIEL and a stock with a share structure that is much, much lower. Key difference they seem to be forgetting is the float. If this was trading this low with only a couple hundred milly on the O/S and float, then I could see a VERY drastic spike.
One thing that I see is that some supporters seem to think BIEL and ActiPatch exist in a vacuum here in the US.
~Ivivi had similar SWT tech cleared by FDA in late 2008.
~OrthoCorp has a portable SWT knee device that was cleared by FDA in late 2009.
Yep, they'll smoke weed and/or take cannabis supplements/edibles
Safety really wasn't the issue with FDA. The main safety issues cited in the original proposed rule were for higher powered devices that generated heat (if I'm remembering them correctly).
Someone on a messageboard (for both current and potential new investors) stating that BIEL has non-dilutive means of funding the company (up to $5M?) when there have not been any public filings to suggest so (to my knowledge) does raise several significant questions if true. IMO, requesting proof of such a claim is not too much to ask.
I've seen the proponents of the company also make such requests to the other side of the argument, so does that overestimation of self importance apply to them too?
Thanks I guess
Conversations/debates have taken an odd turn the past few days
I'm not really sure how BLA became a topic here. Can someone provide a brief summary?
FWIW
Biologics License Applications are under FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Pre BLA meetings are type B.
http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm361331.pdf
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
BIEL is dealing with FDA's Center for Devices and Radiological Health department (CDRH)
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/
From what I've read, the companies request meetings with FDA. FDA then decides whether or not to grant those meetings. Those meetings fall into 3 categories: A,B,C. More in depth coverage of meetings with FDA can be found here:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/04/fda-revises-formal-meetings-guidance-for-pdufa-products.html
Haha, I didn't want to name any names.
I'd have to figure that it may depend on the judges involved and the quality of the lawyers. SEC found a way to improve their success rate, as we may find out soon. In any case, not worth the money/stress fighting the issue in court. Better to ask permission than beg for forgiveness.
A person did threaten to report someone for posting a correspondence. That wasn't my opinion. I watched this play out in the June of 2014. A poster was badgered into posting his correspondence with FDA by several other posters in order to prove his point, then one of those posters threatened to contact FDA about the post. I was amazed by the exchange at the time. It was eye-opening about this board. I'm not going to veer to far into a ToS issue, so I won't name any posters involved.
The logic here makes absolutely no sense. I'm not going to travel down this rabbit hole any further.
I was more or less warning GetSerious not to post any more info.
If you have contacted FDA, then you know what I'm talking about at the end of their emails.
Problem is that if he posts the exact correspondence without permission, a person on this board has threatened to report such posts to FDA as breaching the confidentiality agreement as stated in FDA email signature.
OK, I'll have to go back and listen to it. Thanks.
No, what I'm pointing out is that the document you keep posting wasn't as significant to the reclassification process as you keep stating. The scope of the meeting and the process was provided. The document may have more significance towards the approval process. The burden of proof is on BIEL. As I said before, the 180 degree shift in their position to agreeing what FDA originally said when they kept rejecting BIEL isn't a good look in an argumentative POV.
No where did I say FDA shut down OTC pathway for SWT devices.
I must've missed his attempts at pronouncing "opioid".
Yeah, he is a businessman first. In the 2013 advisory meeting, he basically made a pitch as to why Actipatch should be cleared. The panel wasn't meant for that. The doctor that accompanied him helped him save face a bit by discussing the science behind Actipatch. Their presentation opened the door to a little bit of levity.
Have I read the 2012 document you keep posting in this forum? I have reviewed it.
I have also reviewed the 2013 Executive Summary from FDA
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM352560.pdf
which addressed BIEL specifically
Andy believed the mechanism of action for Actipatch was thermal up until the classification of shortwave therapy devices as non-thermal, class II devices. He was all aboard then. That contradiction probably hasn't gone unnoticed by FDA.
LOL, just me confused - sorry. I'm watching many stocks at the moment for 2016 and 2017. Can be good for awareness purposes, but confusing when it comes to key dates.
I know several on this board watch different MJ stocks. The recent pop for GRNH was preceded by some action with other MJ stocks. Might be due to the rumors of a buyout of a certain MJ pharma. Some of the other MJ stocks that popped in the last couple of days didn't hold their gains, so it wasn't surprising that GRNH didn't hold its gains. Sector not ready to run (yet). Keeping the fingers crossed for the end of the year and into 2017.
That is my bad, I'm getting the fiscal year end of companies confused.
He's not going to tell you specifics until the financials are publicly released. If history repeats itself, we should see a notification of late filing in the coming days.
May go back to the biphasic effect and finding that happy medium.
https://www.leafly.com/news/health/how-marijuana-affects-the-brain/
Thanks for the article.
I hadn't thought too much about preterm births or the baby's weight at birth. Immediately after reading the article, I wonder how frequent people smoked, and what the potency was. Data control is one issue with these studies. That is why we need a more standard set of guidelines for these studies. One thing that FDA-related studies can do is monitor dosage and frequency for each patient. In the case of marijuana, it would be the reactions towards different potency levels. Weed with 5% THC probably won't affect the body/mind the same as 10%, 15%, 20%, etc. End of the day, more data is needed.
The end of the article highlights more of what I would like to see with respect to marijuana use by pregnant women:
OK, thanks for the feedback
You have familiarity with SEC actions. Any thoughts on BIEL's upcoming date with the SEC? I'm thinking that the SEC is looking for something much more harsh than the slap on the wrist Maryland gave BIEL years ago.
https://www.sec.gov/litigation/admin/2016/33-10036.pdf
https://www.sec.gov/litigation/apdocuments/ap-3-17104.xml
Right now, perhaps. Andy had better tread lightly. No one will know if they aren't following the rules until another action commences by FDA and/or SEC.
If Actipatch is being distributed in the US, and Andy doesn't know about it, someone better tell him so he can proactively stop that distribution. If he does know about it, and FDA finds out, the penalty will be more severe this time around than a warning letter (3rd most severe action FDA takes).
That's a big "if".
As it was pointed out many times before, BIEL was warned about not following a securities law. If that situation didn't relate to this situation, then I doubt the SEC would have mentioned it in the complaint. It is the job of the CEO to make sure the rules are followed.
Many brokers will still allow trades on stocks that have a DTC chill on them. Some do not. The chill was lifted in early 2014.
http://www.prnewswire.com/news-releases/depository-trust-company-dtc-lifts-chill-on-bioelectronics-shares-251185661.html
The BIEL chill was talked about on this messageboard years before it was lifted.
Not sure how it's bad press for SEC. If a company is performing illegal transactions, then it would look bad if they didn't do anything or enough. There are already complaints that the SEC doesn't do enough to oversee pink sheet stocks.
Keep in mind that SEC has a higher success rate in the admin process as opposed to regular court too.
A trading halt is done by the exchanges at any time.
SEC can suspend any stock at any time they wish (for 10 trading days) if they suspect there is an issue with the trading with the stock (ie. illegal trading, lack of accurate public information leading to wild trading, etc). Yes, SEC can suspend BIEL at any time without warning if it feels there is something suspicious occurring with the trading of the stock. Suspensions are usually the kiss of death for the stock.
https://www.securitieslawyer101.com/2014/sec-trading-suspensions-101/
50%
Anything can happen with the Pink sheets, esp an MJ stock. You can make an argument that the stock goes to .006, .06, or .60 going into 2017. Still strong interest in the sector that crosses into mind-boggling. We saw what happened near this past spring. Larry Flint was linked to an MJ stock that spiked at a market cap of $2.5B this past March and didn't have the fundamentals to justify that at all (stock was eventually suspended by the SEC). Enough hype going into the elections and ballot measures could prop the sector up. It's a waiting game right now.
The article seems to either be click-bait or written by someone who needs to perform better DD. Seems like the issue is with Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA) not the federal FDA. Formed in 1996, RMHIDTA covers Colorado, Montana, Utah, and Wyoming.
http://www.rmhidta.org/default.aspx/MenuItemID/653/MenuGroup/RMHIDTAHome.htm
http://www.fda.gov/default.htm
Keep in mind that the federal FDA stands for Food and Drug Administration and has a .gov website domain. A ".gov" is used for federal government organizations. The article refers to RMHIDTA as a Federal Drug Agency and abbreviates it as FDA. Also, their website has a .org in it address. A ".org" is normally used for non-profit organizations.
The author should have clarified this in the article if he knew the difference between the two organizations.
Thanks for the info.
No, you misunderstood. 15% was just an arbitrary number, not an upper limit. In the Weed documentary, Dr. Gupta mentioned that the potency of the weed smoked back in 2013 had averaged 13% THC. I adjusted it up a bit since it had been 3 years, and more than likely that average number has increased. I do not expect potency at that level to be an issue unless there were incidents with a particular strain being smoked that I haven't heard about.
I have read the claims within some reports where the THC potency for some dabs was anywhere around 70-90%.
I would need more information on the studies for lower CBD potency and seizures.
I said it in one of my original statements. I believe that up to certain levels, people should be allowed to freely consume marijuana derivatives as they wish. If you want to go to a dispensary and buy some weed with perhaps 15% THC, then you should be able to do so as long as you are over 18. If you want to take extracts with up to a certain amount of CBD, then you should be able to freely do so. My main concern deals with those who like to dab, esp young adults. Medicinal grades would require a prescription from a single doctor. This would also help track patients health over time for higher dosage.
Our debate centers more along of me seeing potential issues with consumption of much higher doses of THC (and perhaps much higher doses of CBD) and wanting more data. I see it as overly-saturating the brain with more chemicals than it can handle, so it may have negative implications over time. As cited by JAMA, most of the data we have now has issues. I'll extend that to having flawed data for both sides of the argument. You appear to want to just let things be and then we'll see what happens.
For me, DEA is a separate issue mainly b/c of their stubbornness. FDA can be wrong, but that can be due to the amount of data presented at the time. As the example I gave in shortwave therapy vs diathermy, they admitted to being wrong in a proposed rule and modified their position when convincing data was presented and they talked to scientific advisors.
The problem with regulating companies and not regulating dispensaries will create legal conflicts. Home growers will do whatever they want as they do now anyway, legally or not.