Important ORTC PR: 1 Mar 2000, 2:54 p.m. Eastern
Ortec Presents at Cruttenden Roth's Twelfth Annual Growth Stock Conference
biz.yahoo.com
This PR discusses preliminary trials of CCS for venous ulcers (a $1.345 billion per year market). "Dr. Katz [Steven Katz, Ph.D., ORTC CEO] reiterated that this data, albeit preliminary, was compelling in comparison to any other published data relating to venous ulcers."
Looking forward: "Dr. Katz said that additional clinical data generated in this initial trial is expected to be available during March. After completion of a planned interim analysis of this data, expected to be finished during April, Ortec will request permission from the FDA to initiate a pivotal trial in venous ulcers."
And: "Ortec also announced that an abstract entitled 'Preliminary Clinical Outcomes on the Use of Composite Cultured Skin for the Healing of Venous Ulcers' will be presented at the Symposium of Advanced Wound Care to be held on April 1, 2000 in Dallas, Texas."
The PR also updates us on the status of ORTC's filing for a Humanitarian Device Exemption for the use of CCS to treat Epidermolysis Bullosa, Erythema Multiforme, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis. Katz said, "Ortec is currently responding to information requests by the FDA, and believes that it can provide all of the requested information in a timely manner. Allowing for the standard FDA review and response time, Ortec believes that, barring any further requests for additional information from the FDA, approval could be obtained by mid-year, which would be in line with our previous projection."
Here's my earlier review of the slides ORTC presented at the Cruttenden Roth conference:
Message 12947248
Here's a summary of my DD:
Message 12924632 |
