These guys had the FDA at their offices in May. Mary Malarkey sent them the letter in Sept. You just hear about it today. The diabetic foot trial they have been bragging about will never be published by any credible journal. These guys didn't even let their shareholders even know about the letter. Their Largest Shareholder sold 1 million shares at 24 dollars. With all these shenanigans no wonder Mary Malarkey wanted to check in with Mimedx. Graffix never got past CBER . Where Epifix was grated approval. The injectable Amnio Fix has "NO LIVE CELLS" I bet we get the FDA's blessing on the 28th!
wow this post makes my head spin its so FULL OF BS and sillyness...
-FDA inspections are part of the Bio process...May June Inspection was expected and is a non issue!
#$%$ letter was expected and RESPONSE was delivered by OSIR but not part of Public Discourse(standard policy)...
-We hear about it today because OSIR has a fiduciary Responsibility to inform SHDRS that they have responded and worked out details of the BLA! Thats all Good,,nothing wrong there!
-The DFU trial is GAME CHANGING..it will be Published and has been presented at two medical meetings already! "Symposium on Advanced Wound Care (SAWC) in Las Vegas on Friday, September 27, 2013. Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, will discuss the primary and secondary endpoints as well as additional key safety data from the trial."
-The shareholders who sold shares at 25-27 took a HUGE profit at 10 basis...thats 250% so I would do the same...I bet they all BOUGHT BACK YESTERDAY! I did!
-MM at FDA is meeting w/ MMDX later this month on their strategy....so what?
-Live enriched stem cells are what you want to HEAL TISSUES...they spring into action as soon as they touch the wound surface....
Protocol 302 is a single-blind, randomized, controlled multi-center trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients were enrolled at 19 leading wound care centers across the United States. Patients between 18 and 80 years of age with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were randomized to Grafix or control dressings at a 1:1 ratio. prior to randomization and between 1 cm2 and 15 cm2 in size.
Ulcers had to be present for at least 4 weeks prior to randomization and between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly for up to 12 weeks. The primary endpoint measures complete wound closure by 12 weeks as determined by the investigator and are confirmed using an independent, blinded Wound Core Lab. Secondary endpoints include complete wound closure rates for those patients that complete all scheduled treatments, time to wound closure, number of applications, proportion of patients achieving at least a 50% reduction in wound size by day 28 and number of re-occurrences. Patients randomized to the control group who did not heal within 12 weeks entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.
Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a flexible, conforming membrane that provides a high quality source of living mesenchymal stem cells (MSCs) and growth factors directly to the site of the wound. Grafix is produced by BioSmartTM Intelligent Tissue Processing of human placental membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors....
....""The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors....""
I worked at the VAMC-DC on this stuff from 1987-1993 w/ the drug CIPRO to control Infection..to be effective a good DFU TX needs all 3 of these(above) plus good Surgical Care, Revacularization IF needed, Diabetes Control, Debridement of the Wound, Daily Cleansing and Dressing Change, Antibiotics, and GRAFIX reapplication daily until complete Closure!
Wrong. Parker's in the back with the meat grinder on that product - it's DOA. And Mills settled in three days, Parker's still waiting. MDXG would be at $4 or below if AF and crew were attacking it. It appears they are all quiet for some reason...wink, wink.
baby, so I guess Medtronic, the largest device maker made a bad decision to distribute for MDXG? Again, Medtronic. MDXG hasn't yet issued guidance on the potential Medtronic sales moving forward. MDXG raised guidance and will report breakout earnings.
Injectables are a fraction of MDXG business. OSIR is depending on biosurgery products.