It doesn't really matter if it can remain on the market if there is no coverage with payers = little to no revenue. It is basically similar to being pulled from market until potential FDA 2015 approval.
You open a yahoo account on Oct 26, post a question for us while posting that you have a sell sentiment? Sounds like you already made your decision. Why ask us? I'm sure you will be one of the many new yahoo accounts that disappear from here after MDXG takes the next leg up.
Read Petes letter to CMS. Intelligent minds can put it together. CMS will crush the major competitors with higher cost structures. Reimbursement will change for the industry post ACA from MDXG to the largest device maker, Medtronic.
The settlement between OSIR and FDA might provide us a big clue to how things may conclude between the FDA and MDXG.
We now know that the FDA will regulate Grafix has a drug and the product will require a BLA. In addition, Grafix will remain on the market. The letter to OSIR was dated on Sept 26 and OSIR settled in less than 30 days. An interesting question is whether or not OSIR fought the decision or agreed with FDA for a prompt resolution.
FDA wishes to regulate the injectables as a drug as well and is requesting a BLA...anybody see any pattern here? It would appear that the injectables should remain on the market regardless if it's classified as a drug or not. I would think this decreases the "uncertainty" factor.
Regardless, MDXG will need to fund trials for the injectables for the payers. Too many people forget or do not realize Amniofix is essentially cash pay. Product will not grow considerably without reimbursement.
You would be better off stating WHY Grafix may be superior. We had these discussions. Many of us here work in medical and talk to physicians who have used both products.
You could also simply give posters 20 thumbs down to make you feel really good about yourself. That's an easier way out for you.
The WSJ article should help attract many new investors with deep pockets.
First, shame on the author for making it appear that the FDA is scrutinizing 95% of MDXG's placenta business in the initial portion of the article. That was misleading and the author should know better. Especially considering that this is the prestigious WSJ. It wasn't until the bottom that we receive clarification that the INJECTABLE business is 15% of the potential revenue. That means at least 85% of MDXG's is fine. Revenue guidance remains the same.
WIth that being said, lets not forget who the audience is. WSJ has sophisticated readers and most are certainly intelligent enough to view the big picture and can subtract the minutia. We aren't talking about the audience who read the Yahoo news articles and type some of the most nonsensical posts in the comments section.
WSJ has a circulation of 2.4 million. You can bet many with deep pockets and who had no knowledge that such a technology exists.
For those reading, welcome to the message board. Epifix is slowly replacing Dermagraft and Apligraf as the wound graft of choice. With managed care changes, it should only benefit MDXG as this product will save the system an enormous amount of money.
I learned about this stock from physicians who are treating wounds on the front line. The only question in my mind is when will the company be bought out and at what price. Epifix alone will have many companies knocking at our door. This is easily a triple your money from here.
I wouldn't worry. OSIR is a little shiny to analyst(s) due to the Grafix multicenter trial. Many of the Biotech analysts lack a sales / marketing background and come up with simplistic conclusions, IE product Data = sales. Product data does not drive everything. As I wrote in Epifix vs Grafix (upsetting the OSIR crowd hence the thumbs down without responding to me), MDXG is so ahead of the game in terms of product adoption it isn't funny. A product that is ready to go on the shelves for immediate use has a HUGE competitive advantage vs a product that has to be planned by staff for use a day before, etc. in an era of decreasing reimbursements and physicians seeing more patients. Empirical evidence (important) is piling up with key opinion leaders, aka the physicians. Don't even get me started comparing the sales force of MDXG (formerly employed by the market leaders who already know the physicians) vs OSIR. The respect for MDXG will come in due time as the sales continue to pour in. Yes, analysts are missing this big and just don't understand the battlefield when looking at data from their cubicle. They need to get out in the field and see what's transpiring.
September 26, 2013
VIA FACSIMILE AND UPS
C. Randall Mills, PhD
Chief Executive Officer
Osiris Therapeutics, Inc.
7015 Albert Einstein Drive
Columbia, MD 21046-1707
This pending CMS decision could really change the ball game for all shareholders in 2014. Bigger than Medtronic deal IMO because it will *force* physicans to change behavior which trumps any sales force tactics. Pete's letter to CMS appears ecstatic without little or no concern for consequences.
I don't give a flying rates #$%$ about Petit. I'm here for Epifix. The top physicians in the country are using Epifix because its highly efficacious, easier to use, and cheaper than the current product line. I follow the money. The trends.
Apligraf and Dermagraft sales representatives are fighting to sell for MDXG. That tells you alot. Those two products are worth 250 million. The companies are losing marketshare.
So what do I care if Petit runs the company or not? Epifix is on cruise control. I challenge you to convince the audience otherwise.
I assume you mean't additional coverage. With the CMS 2014 proposal limiting graft payments to 840, I would expect Mimedx to have coverage under all 9 Medicare regions asap. I would expect that CMS desires the competition within the class in order for their proposals to be somewhat effective. From there cvg should snowball. We are talking about MDXG providing significant cost savings to the entire system both government and private payers. Significant increased revenue potential.
How can it be dead money when there isn't dead earnings? This isn't a developmental stage biotech that has products in clinical trials. This is a company with a product, Epifix that is on the market and growing marketshare and revenue. It's a 100 million product and Dermagraft/Aplifraf reps are selling it because its BETTER and cheaper. This is when I receive silence. DO YOUR HOMEWORK. Epifix is on the shelves. Don't be an idiot
Regardless of how the FDA rules, there shouldn't be much to rejoice about. Fact of the matter, the moneymakers for the injectables segment to this point have been Amniofix and Epifix micronized (the ~15%).
Amniofix isn't covered by payers and will require studies for reimbursement regardless of how the FDA rules. It's essentially a cash pay product that is being used within the clinic like PRP (Platelet rich Plasma). PRP has been around longer than Amniofix and it continues to lack insurance coverage. PRP costs the physicians less than Amniofix, typically giving physicians higher profit margins and an incentive to try PRP first. Amniofix cannot drive significant revenue without the payers. Retaining Dr. Gary Stanziano is a move in the right direction.
I've had Amniofix on both of my knees. It's a great product but it's a 5-10 year project. Again, it will require data before it can provide significant revenue. I can see Amniofix being used like hyaluronic acid or a steroid in athletics, etc in a decade. Amniofix is the speculative play. In the meantime, Amniofix is competing against steroid shots, surgery etc that is covered by payers.
Epifix micronized was made for physician preference. Can't see how this makes much of a difference monetarily if it's off the market.
The immediate revenue growth remains with Epifix. There is a potential windfall waiting with the CMS proposal for 2014. May be a good reason why the CEO wrote a letter to CMS providing support, for the most part, in the decision. It would be difficult for MDXG to calculate the revenue potential but you have to figure its a game changing policy change.
I've been in this stock since it was 1. It appears that the uncertainty remains with how law firms will approach upon the FDA decision. Is there any precedent? How many shareholders with 50,000-100,000 in stock losses could be retaining council? Will it be a continued nuisance? Legal fees, etc.
This should be a great transaction for both companies. With GPO / IDNs you need a company like Medtronic that can leverage itself like a Wal Mart and become "One stop shop." Medtronic is certainly the cadillac of the med device industry.
Before that, Smith & Nephew abandoned Dermagraft and sold the product to Advanced Biohealing after a failed leg ulcer trial. I'll see if I can re-dig up "why" it have failed in the Smith & Nephew days.
Are you happy about this cimcbride? How much did OSIR spend to develop Prochymal vs the 100 million that they sold it for? I thought the MSCs were the rage at OSIR.
Until Grafix can capture a significant marketshare, I'd hold off from calling it a "major" competitor to MDXG.
The law firms usually announce the launch of an investigation before filing an official lawsuit.
Free advertising on WSJ, ABC News, etc over what is essentially icing over the cake (short term at least). As I said before, I'm sure MDXG is on the watch list of many pockets after the publicity.
I'd like to see these lawyer press releases get out of the way so we all can focus on the big picture again.
Good for MDXG to secure a meeting with FDA a couple of days before earnings release. Worst case, If the FDA meeting goes really bad, I'd expect a press release from management asap indicating the removal of injectables to usurp any further allegations. We can price that in and await potential good news from release (3 MACs) for a nice leg up.
The injectables are a bonus short term and the next phase for growth 5-10 years out (expect MDXG to be bought out). Amniofix is being treated like PRP with payers as "investigational" until more data is provided.
MDXG got hammer by attorneys for not issuing a press release within a couple of days of an untitled letter regarding their injectable business (small percent of revenue). This letter came after MDXG and OSIR did not alert shareholders within the past 25 days. Why?
Grafix contains LIVE viable cells (MSCs). That is the complaint in the letter. Epifix does not contain. MDXG is the strong buy.