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Glad to hear that you have volunteered as a BIEL Guinea Pig seven!!
Keep us posted on your progress. When I use the ActiPatch on my lower back there is a definite increase in blood flow to the family jewels.
I agree about the squeak getting attention in the business world. Inquiring in a respectful manor as to why the FDA has not met Their Own timeline on PEMF reclassification (not BIEL reclassification) is not out of line or going to delay the process.
If everyone who is interested in a timely conclusion to the reclassification of PEMF devices, the FDA's own proposal now past its own 180 day completion goal, were to politely write to Ms. Burns it could have an impact. The FDA is a public agency. If enough of the "public" rattle their cage, politely, it has to have an impact.
mailto:Melissa.Burns@fda.hhs.gov
Reply to an inquiry that I made to Melissa Burns @ FDA:
Unfortunately, I cannot give any specific estimates on when a final order will issue. The comment period is closed and we are considering the comments received on the proposed order. The amount of time for development and review of FDA’s responses to the comments and the final order itself is reliant on the types of comments received and ongoing balancing of priorities. We are aware that there is significant interest from manufacturers, patients, and other stakeholders in us bringing this classification effort to a timely conclusion.
Regards,
Melissa
Fear not StockinUp, no canine orifices were compromised in this study. One of the pictures in the link shows the PEMF in action. We will use PG protocol and call it external, lower tummy application.
I think the dogs in this study were all truly "Lucky Dogs". After the Treatment they could run around all day with their friends and not have to stop for a bathroom break every 30 minutes, unless of course trees and fire hydrants were near. And considering the semen samples that were analyzed everyone had a happy ending.
http://www.ncbi.nlm.nih.gov/pubmed/24913937
PEMF and Prostates. A canine study released last month found that 3 weeks of PEMF treatment on 20 dogs with Benign prostatic hyperplasia (BPH) reduced prostate size by an average of 57%. No negative side effects were reported.
50% of US males have some level of BPH by age 50 and the percentage grows larger with age.
Come on FDA, lets make this technology available.
http://www.ncbi.nlm.nih.gov/pubmed/24913937
They are probably approved for one indication for use via prescription just as Bioelectronics is FDA approved for Blepharoplasty, eyelid surgery, by prescription. In selling through the internet the company or a distributor is doing what BIEL did until they received a letter from the FDA demanding a stop to this activity. The MD Cure device is not approved for OTC sales.
Thanks for the Cuvamove info yankee, further proof that pemf is a viable technology. At $1500 the Curamove requires a significant investment as compared to the Actipatch $29 cost. Curamove is promoted as a portable device but strapping on a 6"x4" box that weighs 250 grams is a world away from the Actipatch at 8 grams and invisible under clothing.
For me the extra time that the FDA is spending on our reclassification is a positive as I have been able to add to my position.
Any theories on why we had a 87% short ratio on 8/11?
date................short vol.....total vol.
20140815|BIEL|1786811|0|18934625|O..................................
20140814|BIEL|2983889|0|5852889|O...................................
20140813|BIEL|2715691|0|4636091|O...................................
20140812|BIEL|3089000|0|9107000|O...................................20140811|BIEL|12220456|0|14049232|O
Pet Patch Review: I decided to join seven-up and purchase a Pet Patch for my mule. The new Patch has several improvements over my 4 year old ActiPatch.
1) The wire loop has gone to a heavier gauge, about 14 vs about 18-20 for the old Patch. I wonder if it has had an effect on potency.
2) The foam pad on the back of the old Patch is gone. This is probably a good thing as the foam was most likely a bacteria sponge.
3) No more sliding the plastic wafer between the battery and circuit board to kill power. There is a slick push button on/off switch in the center of the back side, also a pop on safety cover for the switch to prevent accidental activation/deactivation.
4) The circuit board is now completely encased in plastic. This gives the unit a more sleek, professional look and reduces the thickness from 3/8" on the old to 1/4" on the new. Those who replaced batteries on the old Patch may be out of luck with this new design.
5) The pilot light that tells the user the Patch is active has changed color from red to green and is noticeably brighter.
6) Glad to see that Heal Fast charged the actual $5.05 cost for its Priority Mail delivery service.
These changes have made the Patch a much more professional, user friendly device. My mule will be very happy.
Thanks for shedding some light on the process Simpsonly. If there is a Letter of Intent before the FDA decision do you see the interested party working with BIEL towards an FDA OTC approval?
Yankee, I feel that this is the best scenario for BIEL shareholders. Building brand awareness for a Bioelectronics Actipatch on US shelves is a multi year, multi million dollar endeavor. A Pfizer (or insert your favorite big pharma name) Actipatch has instant brand recognition and clout in the marketplace.
I am looking closely at adding to a 6 million share position on this information.
If AW is being honest about the interest of a big pharmacy company I would say that our odds of an OTC classification, which IMO were already good, have improved dramatically. If Abbott, Pfizer, ect. thinks that there is money to be made by licensing the Bioelectronics technology they will use their FDA contacts, lobbyist and expertise to ensure a favorable decision.
If BIEL is so "horrifying" mightylion why do you continue to spend your valuable time posting here???
Terribly sorry for the misunderstanding arizzle. So you are saying that we should Buy Bioelectronics not sell.
iMRS 2000 with HRV Biofeedback is a $3200 plug in machine. Not exactly in the same class with the $30 Actipatch that can be worn at work, running, cycling, hiking, ect.
This comment by the "Patient, Consumer, and Public Health Coalition"
is from the 2012 process. When I look at the public comments on FDA Docket No. FDA-2012-N-0378 they are all dated 2012. Where do we find comment on the current Class III to Class II proposal?
You can buy the PetPatch Loop from HealFast. The specs look the same as the ActiPatch. $29 http://www.healfasttherapy.com/dogs/petpatch-loop/
This was their best shot, with the lawsuit news they were shorting 50% of the total volume and only hit 1.65 . Time to throw in the towel and cover boys!
You had better keep a close eye on it if you want back in. When it hits the short capitulation point their 19 million covering buys will move it up rapidly.
The only problem with Smallcapnetwork's theory is the article was written this morning. Sirius rallied in the afternoon closing @ $1.12, 1 cent above it's $1.11 open, up 2.75% over Monday & did this with the Dow down 100 points. This is not a sign of weakness. Not too bright of them to make an assumption like that with the volatility of Sirius, the push to keep it over $1 for 10 days & the earnings show on Thursday.
The Class Action settlement was the tell for me. Plaintiffs accepted millions of shares as part of the deal. You have to believe that sqnm showed the lawyers more information than is publicly available or they would not have made that deal.