REALLY encouraging numbers for the week of 5/30. Most drugs I follow down 10-17% because it was a 4 day work week with memorial day so its normal for numbers to take a big hit BUT for week of 5/30, TRX 249 vs 204 for prior week, UP 22%. NRx 174 vs 143 prior week, up 22%. Encouraging.
Not too exciting. TRx 204 vs 218 week of 5/16. NRX 143 v 176 prior week. Keep in mind with any new release there are always some down weeks, as long as it doesn't become a trend
Bad news folks. I am, for the time being, "out of commission" in terms of script date. Trying to get it back but even if I do, not likely it will be today
..."A last minute switch by 3 panelists on the efficacy question ended the day with a bizarre twist, given that the panelists had earlier voted overwhelmingly in favor of device efficacy @12 & 18 months. Hopes remain high that VBLOCK should get FDA approval based on the benefit vs risk vote.. In our opinion, the fact that the FDA asked the panel as to what should be a "reasonable" consideration of weight loss (as well as the definition of what type of weight loss should be used) was in and of itself emblematic of how complex obesity is, and nailing down a rigid protocol remains problematic....Overall, it seemed to us that the FDA had a relatively benign outlook towards VBLOC therapy especially given the multi-factorial nature of the disease and the clinical effects seen with VBLOC. In our discussions with the company, management believes that the Lerner template for weighing devices based on risk-benefits would trump all other concerns, and the positive panel vote on that metric bodes well for approvability of the device. Outperform, Price Target $7.00
Correct Tips. Pete actually increased his holdings as part of the combined transaction at the time. Pretty complicated financial stuff for a kid like candy to grasp so don't be too hard on him.
Good stuff from old_wisetrader from OSIR board
Ozark, don't shoot the messenger, someone very knowledgeable with the wound care business has asked me to provide you with some facts regarding your conversation on studies.
I’m not too sure about the Grafix ‘high quality trial’ that you mentioned. Yes, they had 90 some people, and it had purported good results. Frankly, they should have – the population in the study had wounds that most likely would have healed on their own. Anyone who has been around wound care knows about the Sheehan study from back in 2003 that basically proved the trajectory of wounds that heal on their own with conservative therapy vs. those which need advanced therapies. This study is the basis for reimbursement and treatments in wound care and has been so for a decade or more. This basically said that if a wound area is reduced by 12.5% or more in a week, 25% or more in 2 weeks, or 50% or more in 4 weeks, it will likely go on to heal without any advanced therapy interventions. Now to the Grafix study – they allowed DFU’s with wound area reduction up to 30% in ONE week to be in the study! These are the easy to heal wounds! The EpiFix studies excluded anyone who healed more than 20% in TWO weeks, so their wounds were harder to heal. Also Ozark – you mentioned the demographics in the first EpiFix study, but you failed to mention that they did a cross-over study with the control patients and they healed at 90+% in about 8 weeks, so your argument does not hold water. Plus the 40 patients in the 1 week vs. 2 week EpiFix study with a 90% healing rate.
andre, why don't you go f#$# a squirrel.. Anyone who wants the data feel free to email me at homebuilder_watcher yahoo email
Wait, the company that bought Dermgraft for ZERO from Shire with only potential future payments if sales meet certain numbers (sales that are tanking from all reports because Dermagraft can't compete with EpiFix) and SHire, whose marketing practices for the product was under investigation by the Justice Department (see below), lodged an advertising complaint against MiMedx? Do I have that right?? I guess when you are trying to sell a product to a market which finds your product laughable compared to your competitor, you have to try something! Organogenesis has nothing to lose since they paid nothing for a worthless asset that Shire took a $650 million loss on just to dump it from their balance sheet.
Shire is generally retaining legacy liabilities relating to the DERMAGRAFT business, including the previously announced Department of Justice investigation relating to the sales and marketing practices of Advanced Biohealing, Inc (now known as Shire Regenerative Medicine, Inc.).
Shire will receive no upfront payment from Organogenesis but is entitled to receive up to $300 million cash in total milestone payments should Organogenesis meet certain annual net sales targets between now and 2018(1). Shire will record a loss on disposal and associated impairment charges of approximately $650 million in the fourth quarter of 2013, which will be excluded from Non GAAP earnings.
Will try this once more. You can go to medscape website and search for epifix in the search box in upper right side there. Amazing how difficult yahoo makes it for someone to post useful information yet it is a breeze for spammers and bots to post
Funny stuff market_mania/Halloween_candy. Epifix is superior to Grafix on every metric. Many doctors have weighed in who have used both and not single one opted to use Grafiix over EpiFix. But, keep on telling yourself that Grafix is better if it makes you feel better.
market_mani, why won't "your" CEO answer the question? Hiding the lack of Grafix sales?
William Plovanic - Canaccord Genuity
Okay. As I look at the business, the question is always, how much of your business is coming from this split between Cartiform, Ovation and wound care? Or, if you're splitting it up, how much is from orthopedics verse wound care? On top of that, Stability Biologics, are they all of your orthopedic sales, or are they just a component of sales?
Lode Debrabandere - President & CEO
We haven't broken down the numbers, and I don't plan to do this in the foreseeable future. We might change that down the road, but for now we don't.
In terms of the orthopedics, Stability Biologic is an important partner for us and is working on the orthopedics side. Having brought a drain on and the expanded team in sports medicine of little bit as well, we do start to have more of a balanced approach here. Overall, Stability remains an important partner for us.
Like I mentioned, Cartiform -- your question was around Cartiform. As I mentioned before, I didn't really highlight Cartiform or OvationOS right now, in this call, because we are still way more in a extensive clinical evaluation phase for these products. That's what I prefer to do is collect the appropriate data, take your time, do the right things.
The issue with these, the issue which is pretty normal, but what the clinical endpoints are for bone growth and for cartilage repair, it's not a six-week, twelve-week wound closure endpoint. It's a two-year endpoint, so it takes more time to fully assess the role and the benefits of these products. That's why there's more focus on the clinical side to push this products forwards, than on the commercial side.
William Plovanic - Canaccord Genuity
Okay. But, to go back to the wound care orthopedic, to ask a different way, you went from about $4 million to $10 million year over year. Nominally, was the driver of that orthopedics, or nominally, of that $6 million i
Anyone read his note today? He (and in my opinion his short friends) are getting more and more desperate. AS the situation at MDXG gets better and better he keeps writing more and more notes explaining why he is "neutral" and why the future is bleak for MDXG. he hades two new "problems" ahead for MDXG today, one is not knowing how the acquisition by Medtronic will affect the distribution agreement between the companies and the other he brings up is the competition ahead for MDXG with ALQA, a company projected to do $4 million in total revenue in 2014. Yes, ALQA poses a threat to MDXG according to Suraj. Just goes to show you that anyone can become an analyst. The standards must be extraordinarily low.
What kills candyass is that he knows Doc, old_wisetrader, me and the other long time longs here are accredited investors ( something candyass will never be since it requires a specific net worth) who were in on the pipe or around that time under a buck and it kills him that we are sitting on a 7 banger which will be a 15-20 banger some time in 2015 while he worries month to month how he will be able to pay his rent on his little apartment and make the car payment on his Ford Focus.