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The scientific papers that Thomas posted have nothing at all to do with Predictive’s regenerative products. Go to Pub Med and search mesenchymal stem cells. You will find thousands of papers on the subject going back many years. These papers represent the state of knowledge in this arena. You cannot extrapolate this information for marketing specific products from a specific company.
The vid is on a private link which expires today, and will not be available for public view until sometime this week is what I’ve been told. Supportive videos will come out next month.
Not sure of all the avenues for release. It is thought that a press release and release on all of the company’s social media outlets. Look for other supportive videos next month to follow this weeks release. I’ve seen the video coming this week and have the link but cannot provide it until it’s released. Very good PR.
Look for several videos to be released to the public, about PB regenerative side of the company, with the first coming out this week. Look for up to 7 additional public videos to come out next month.
I asked my PB rep this week if there was any news on the proposed knee OA IND and if there are any other INDs in the works. The response: all are in the works and they are engaged with the FDA to get clarification on how the FDA sees PB’s products. If the FDA says one of PB products is a drug they have engaged a couple of consultants that specialize in PMA (pre-market approval), and INDs. They hope to have clarification coming up soon.
There are thousands of papers on Pub Med pertaining to MSCs. The problem here is Predictive cannot claim that it’s 361 regenerative tissues can be used to TREAT any medical condition without running afoul of the FDA. The only products that treat disease are drugs, which have FDA approval. Those are termed 351 products. With time and the appropriate FDA sanctioned studies some of these tissues will prove useful for certain diseases allowing the companies to make claims. We’re not there yet and it will take decades to complete the appropriate research.
Thanks for that, Snow. That is why I stated in earlier posts that Regen medicine tissue products is only a small part of their business. The FDA is the 800 pound gorilla in the Regen medicine room and they are flexing their muscle shutting down some bad players. My point, being someone with significant clinical, and day to day business in this field is to be aware of that fact. They have shut down some tissue labs over the past 2 years and are increasing their scrutiny. Like I stated, I am long this company, but nowhere near the amount of shares that some on this board hold. I have no interest in selling what I presently hold. If it goes to heaven, that’ll be great. If it goes to hell I can walk away unscathed.
You’re correct, that’s what it is. Geez.
Show me evidence of the FDA saying Predictive is the gold standard. I’ve not seen or heard that. What article are you sick of? The FDA link I put up? That is straight from the FDA site.
Yep, that’s your choice. What Predictive regenerative products are fda approved? Direct Biologics? Biogenix? Signature Biologics? None, zero, zippo. There are no 361 regenerative products approved by the fda. Why is that? Because they are not drugs which would classify those products as 351. What do you need to be a 351 product? FDA sanctioned studies. None of these companies have them. Although multiple clinical studies exist supporting the use of regenerative products for a myriad of conditions, these are not fda sanctioned studies therefore no evidence. What do you think average Joe Q. Public does when he finds out these products are not fda approved? He walks. Not all, but many. At least Predictive has applied for an IND for knee osteoarthritis and Corecyte. Great step, but no updated news on it since announced. Now if Predictive can get their IND for knee OA done showing Corecyte is an effective therapy for knee OA, we’re going to rock. I’ve seen dozens and dozens of knee OA respond tremendous to Corecyte, but until you have that study it doesn’t mean diddly.
Good luck. Predictive is not the only company I use. Direct Biologics Exosomes, Biogenix, Signature Biologics (Dr. Neil Riordan’s company). Point is there are many companies out there and competition is tough. Don’t bet the farm, because the regenerative medicine field is going to get more volatile in the future as the fda clamps down. Google Dr. Leigh Turner. Protect yourself as there is a certain amount of hype in this field.
I use Polycyte and Corecyte combined or sometimes alone. When the company had the UC Matrix product we used that over PC and CC for joints. The Matrix product was a test product available for a short period of time and more concentrated than CC or PC. Those of us that used it were sorry to see it discontinued. I believe it was a precursor to a future product yet to be released.
I understand your skepticism, and distrust, but I’ll keep that information private. The link I sent you is off the FDA website. I don’t like it anymore than you. On one hand the fda regulates these 361 tissue products, has provided a 36 month window to use them, but then demonizes the use of these products in that video. I did add another small position last week at 1.60. Good luck to all.
I'm in the business daily with patients. I spent over a quarter million last year on biologic tissues not including marketing. Predictive is a great company but the landscape for 361 regenerative tissue products is sketchy. Take a look at this FDA link and a recent video on their website talking about umbilical cord tissue products, including Wharton's Jelly. I know Predictive is more than regenerative medicine products, my point is don't bet the farm.
https://r.search.yahoo.com/_ylt=A0geKYqpSJ5diL8AW0NXNyoA;_ylu=X3oDMTEyMG9rb3ZvBGNvbG8DYmYxBHBvcwMxBHZ0aWQDQjg5ODZfMQRzZWMDc3I-/RV=2/RE=1570683178/RO=10/RU=https%3a%2f%2fwww.fda.gov%2fconsumers%2fconsumer-updates%2ffda-warns-about-stem-cell-therapies/RK=2/RS=zsq0GEaIW3wbepfVMGRF7Nvj.Dg-
I use some of this companies regenerative tissue products but will tell you there are other companies out there with competitive tissues with lower price points for practitioners. I understand this company is more than regenerative tissue products, but wouldn’t bet the farm on it. I know many practitioners that have stopped ordering this companies tissue products for other company products, but that is normal in this business. You also have the FDA regulatory landscape which has been more aggressive against the use of the 361 products companies like Predictive supply. Caveat emptor. I am a small position owner in this stock, very small.
Why even short a stock at this level? What’s the upside a couple of bucks? Your downside is much greater. I just don’t see the risk to reward ratio shorting stocks under 10 bucks. That’s always been my discipline.
Integrative regenerative medicine
I use Predictive’s Regenerative medicine tissue products weekly with patients. Great products and patients appreciate the results. Great rep support for field docs. Regenerative medicine is in its infancy and all of these companies are at the regulatory mercy of the FDA. Keep that in mind going forward. Regen medicine products are not Predictive’s only market.