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Very nice. It looks like those conferences are going well. Exciting times ahead.
That could be a great genre to get in to. True horror films, not the teen horrors or whatever they are called, seem to be making a comeback.
I agree their. Kind of a damned if you do, damned if you dont. They certainly have more experience than I, but would be nice to know there philosophy a little better. They certainly have one with turtle. Toys In The Attic has another great shot. Cook County, It could be a hit with DVD/BR. It seems like those type of controversial movies hit there strides on DVD/BR. This seems to be one of those risk judgements and to my point, was it a calculated risk or a shot in the dark? Having a plate to big early can hurt as well. I think they can reduce there risks in specifying in a few genres, yet still hit a big time movie. They can take a better analyzed approach. Time will tell. they certainly have the experience, and the shareholders in mind, as they proceed.
I agree with your comments. IMO they seem to be doing the right things for the company and the shareholders. They are learning from their mistakes and doing everything they can to get them to where they want to be. They are a small company, in the movie biz, and it is going to take some time to grow. The fools on that board seem to think they can't make mistakes and need to purchase only academy award winning films. One day, hopefully they will be at that point. The only real questions I have is what is there direction for theatrical releases? What makes them purchase one film from another? Why not specialize in a couple of genres? I have not been following the company for very long, so maybe those questions have already been answered.
No kidding. Im wondering if elway is under the helmet.
Should have been the raiders today but my second love in the NFL, watching tebow get destroyed!
Thanks Harley. It would be nice for a 510k, hopefully that is the case. The FDA, like you stated, has lots of info to use in determining the approval process.
Good to see some kind of numbers on the Core. Looking forward to additional stats on that.
The way I am understanding the comments, additional testing may be needed in order to get it approved for the use by non-docs/derms. They seem pretty confident in there stats but more in depth on the ease of use may be needed. With a 2014 release time frame, for the US, it seems VRSEF planned on these additional tests.
VRSEF-
http://www.genomeweb.com/verisante-wins-canadian-european-australian-approval-aura-skin-cancer-dx-launche
Not sure why the link does not work. You can search ProteoMonitor Verisante and the article will come up. Nice article on FDA process for the Aura and a little bit of news on the Core.
Verisante Wins Canadian, European, Australian Approval for Aura Skin Cancer Dx; Launches FDA Bid
January 06, 2012
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By Adam Bonislawski
Having obtained Health Canada approval, Australian Department of Health approval, and an EU CE mark this year for its Raman spectroscopy-based skin cancer diagnostic device, Canadian biotech firm Verisante has begun pursuing US Food and Drug Administration approval.
CEO Thomas Braun told ProteoMonitor this week that the firm expects to have a pre-Investigational Device Exemption meeting with FDA sometime in the first quarter of this year and hopes to bring the device, named the Aura, to market in the US by the beginning of 2014.
He said that given the lack of predicate devices, he expects Verisante will have to take the Aura through FDA's premarket approval process, which is typically more costly and time-consuming than the less-stringent 510(k) regime. In June, the company raised $5 million through a private placement to support commercialization of the device.
The Aura uses Raman spectroscopy to measure the levels of various biomarkers – including proteins, nucleic acids, and metabolites – in skin lesions to distinguish between benign and malignant lesions. By comparing the patterns of spectra generated by the device, clinicians can differentiate between the two.
In a study completed in 2011, the company worked with clinicians at Vancouver General Hospital’s Skin Care Center to test the point-of-care instrument on roughly 1,000 skin lesions. Preliminary results from the first 274 samples demonstrated that it distinguished between benign and malignant lesions with a sensitivity of 100 percent and a specificity of 70 percent (PM 3/4/2011).
In collaboration with University of British Columbia researchers, the company has since completed a paper presenting an analysis of the full dataset and is pursuing publication in a peer-reviewed journal.
Using the VGH data, Verisante secured Health Canada approval in October, CE marking in November, and Australian Department of Health approval in December. The company has also entered the regulatory process in Mexico and Brazil and expects, using the same data, to secure Mexican approval for the Aura this year and Brazilian approval within the next two years.
Braun said he was optimistic that the VGH study would be sufficient to obtain FDA approval for the device, but, he said, the agency might require a multi-site study performed in the US.
“[W]e’ve got evidence that it works. We know that Raman spectroscopy works. And how many cases do you need to show that the device correlates with the biopsy results?” he said. “But, of course, every regulator likes to see data from their own country … so we’ll see.”
Braun suggested, in particular, that FDA might require the company to test the device in a more diverse range of settings to demonstrate that it works well outside of a top-tier research hospital like VGH.
“They might say, for instance, ‘Does this work in an independent dermatology clinic in a rural area or do you have to be a professor of dermatology to use this?’” he said. “Will it work with typical staff [with] a basic education? Will it work in different climates?”
If FDA were to demand an additional study, it would likely take several months and cost between $1,000 and $2,000 per patient, Braun said. He noted that clinical cohorts for the Aura were relatively easy to put together due to the high volume of patients at many dermatology centers.
“A busy skin cancer clinic might see 50 people a day,” he said. “So if the FDA said they want us to do [an additional] 500 patients, there are some busy clinics where they could do that in 10 days.”
In addition to preparing its FDA submission, Verisante is planning to commercially launch the Aura in Germany, Austria, and Switzerland in the middle of 2012. Germany, in particular, is a promising market, Braun said, noting that it has 5,500 dermatologists – more than a quarter of Europe’s total and more than half as many as the US.
Germany, which has a population of 80 million, offers under its state health insurance a €150 reimbursement covering skin cancer screenings every two years for people 35 and older.
In an interview with ProteoMonitor in March 2011, Braun said the Aura would sell for around $30,000. Since then, however, marketing, distribution, and materials costs have driven the price closer to $60,000, he said.
In addition to the Aura, Verisante is working to commercialize another Raman spectroscopy-based device called the Core. This device, which was developed by a team headed by UBC professors and British Columbia Cancer Agency scientists Haishan Zeng and Stephen Lam, is an endoscopic version of Verisante’s Raman-spectroscopy system and is intended for detection of lung, cervical, and gastrointestinal cancers.
With a grant from the Canadian Institutes of Health Research, researchers led by Zeng and Lam are using the instrument in a 200-patient clinical trial for lung cancer. In March, Zeng told ProteoMonitor that preliminary data from the device was "quite good – reliable and repeatable."
In June, the researchers published a paper in the Journal of Thoracic Oncology detailing these early results. Their findings showed the Core detected preneoplastic lesions in the lung with a sensitivity of 96 percent and a specificity of 91 percent. According to the paper, the standard detection method of white light bronchoscopy combined with autofluorescence bronchoscopy has an average specificity of roughly 60 percent.
Hey now I didn't see any preferred shares holding the voting rights here. I demand a re-vote! Lol jk. Congrats Stills, make the board proud!
Who knows with this company. If they ever get something tangible it has the chance of being a mover. They seem to hype everyone up in the first half of the year and then go silent.
I do owe a WC. I am going to ride with MDXG on this one.
Could be the whole song and dance all over again. The past few months have been filed with dead air and silence and now they had a nice article come out. If they truly have something, about damn time. I would say there are many peeps, like you and I, waiting in the shadows for the official word. LVLT and KBLB kicked off my 2011 year nicely, maybe KBLB can do it again.
Pulled the trigger on MDXG on the drop today. May be a little to soon but the more I read, the more I like. Will ride through the turbulance.
I added KBLB and TLON to my watch list today. KBLB may finally be reaching an actual product. Yeah, I know, been hearing the samething for years. Either way, good short term trading stock at its current price under .10. TLON, lots of risk and a pretty ugly balance sheet, however they have an NDA under an accelerated approval process from the FDA. May 13th is the make or break date for TLON.
Liking the vibes of 2012 already. Nice to see HHSE/TDGI break through .02. VRSEF starting its climb back. Damn TPIV and its even day today. What a black eye. Lol.
I think you are right with the run. The RSI has been flat the last 2 months and it is due for a change. the new ticker might be the wick to get this thing lit. If those audits and a nice Q comes out, it could have a good steady run w/o the drop back.
MA- in regards to JBI. Not real familiar with it but it does look like it has been pumped over the past few months, so that's probably why you see it overvalued at this time. I would agree as well. The DD Support board has some good info. I see you have been over there though.
Malc- hope you and your fam, and everyone else on this board, had great holiday. Best wishes in the new year.
MDXG just completed a 5 mil PP. A new 5 mil shares, at a $1, could be on the market now. Saw some interesting stuff in the proxy e-mail about the directors and the options and warrants for the company. Lots going on in that. If anyone wanted to look at that, the proxy is in the news section on Ihub. Sorry for no link, on the phone currently. Will be watching this one for a little bit.
I hear that! Have a great weekend everyone! See you all on Tuesday
Nice. Europe and Australia and now working on FDA. Great news the past few months.
Their is some strong potential for sure. If they can get there CollaFix approved, that is an incredible product and would change the sports world IMO. For now, we will get to see how the management team can handle these bumps now. Thanks for the feedback.
Bash, beat it up all you want. The more I looked at it, the more the PPS is overvalued currently. Killer product though. I have not bought any and will need to see the 4Q. If sales are still stagnant and the rate of burn they have going on is the same, the next news will be an increase in the authorized shares. (100 mil currently). It has held above a buck for awhile, so it will be interesting to see what happens. Thanks for the input.
Anyone familiar with MDXG? Just starting looking at this.
http://www.otcmarkets.com/stock/MDXG/company-info
http://www.mimedx.com/
Add TPIV to the index. I sold IGXT yesterday and got in TPIV. Working on my WC now.
Thanks for the updates on TDGI. Same to you Malc. Looking forward to seeing those on-line sale numbers.
Not holding many at the moment.
VRSEF
TDGI
IGXT
Cool. I was hoping it had nothing to do with results or news.
What's up with TPIV? I have traded that a few times when it got under .18. Have not looked at any data just noticed the price. Good opportunity to pick up some again.
Agree with that. It seems the mms are walking it down to spark some sort of interest. With the no news from the co right now, it may be tough to spark any new investors. I have been thinking if they had a couple more mms working this stock, it might not move down so much. Rough looking at it now with my average at .80, but still think that is a good price on the potential. Will be averaging down with any chance I get.
I did sell IGXT at 55 but just reentered at .46. Will see if this holds in the silence.
TDGI looking strong on the 60 min. Keep pumping them sales Harley. Thanks for the updates with your store as well.
VRSEF is wanting to heat up. Little more volume needed. I think we are due for an update this week.
I think they will add some shares as well but won't be many. They have some good cash on hand now. Will probably have some questions once I go over the 3q again. Right now just wondering if he has a plan for the Asian market. Seems to be untouched and would be a huge target other then the states.
I agree with that. I also like the BOD and staff. Good group of knowledge and experience between them.
I was surprised by the number of companies listed. Competition is a good thing in my book. That tells me there is a strong market for this type of product. Hopefully the marketing and sales department is as strong as the device. It is going to be fun watching this develop over the next few months.
VRSEF- 3Q docs available at sedar.com.
Old posting from stockhouse but a shows a good list of competitors and future competitors.
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=VRS&t=LIST&m=29780802&l=0&pd=0&r=0
The skin scan 650 may be a strong competitor. This device is still in development.
http://www.otcmarkets.com/stock/MBHS/news
A true no bid would be where the ask is at the lowest possible offering price. .0001. No bids can be made lower then that.
It is a shame where that stock has gone. Took a hard loss on that one.
TDGI- took a position today. Turtles looks to be doing very well. Will be an interesting 4Q to read.
Quite day here yesterday. What's up with? Thought I would be reading some serious smack talking! Good to see VRSEF pick itself up a little today. Wishing I had some free cash today to purchase some more.
Michael- thanks for the info on TDGI. Was not really looking to get in but I am certainly going to take a look at it over the next couple days. Seems like an ideal time to get in with the holiday season sales kicking in.
Haven't had a chance to get on here in awhile. Liked the article. Good info put out in that. It is crazy watching that slide the last couple days. At least I was able to find a little extra change and add few more shares. Look forward to your follow up article.
TDGI- I don't follow this company and not sure if this has already been discussed. Noticed the turtle movie was streaming on Netflix yesterday. Just wondering what kind of income that would generate.
IMO with VRSEF raising the price point and saying there machine was undervalued says something about the competition. They originally had a price under 40K and are now thinking 60k is a good price. That tells me two things. They have low manufacturing costs and the competition is priced in the 60K and up. Also, the Aura is just a sample taste from this company. We should hear more about the Core system in 2012. I believe that will be the game changer.
I think you are as close as you are going to come with the numbers the public gets to see. I applaud you in your efforts. Malc needs to throw you one of those PBRs.
I had to read that a few times. It seems that the 5548 number would be used, since they were enrolled into studies. The 6931 were used as a base to begin their studies. Those were uploaded into the system and then tested on 5548 new patients. Out of those patients, it seems that only 3559 were unique and different. The 3559 number was to update there system, so they did not have duplicate images. At least that is how I am understanding it.
Just outside of the 'Cuse. My step dad is a huge bills fan. Had fun watching that shootout between the raiders and the bills.
The talk about the Jets, Bills, and Steelers have me feeling like I am back home in upstate NY. Good stuff. Take out those patsies, sick of hearing about them.
This board is perfect for the noob investor like myself. Already learning some new tricks here and it is good to hear feedback other then this is going to the moon. lol.
Touchdown Raaaaaaaiders!
Thanks for the insight the last two days. I appreciate it. Hopefully interest can pick back up this week. If not, I think we will see this fall back into the 40s, if not lower, like you stated. Thanks again.