OT DORB
Exwannabe, I didn't (did you?) read the PR (copied below) as saying Numoda will do the whole P3 job turnkey fashion, nor that their equity stake means that the funding is taken care of. I don't know Numoda, but it sounds as if they provide some CRO services, data collection and analysis primarily, not the whole deal. If that interpretation is right, then the question remains open of how DORB will fund the P3 - designing the new trial, getting FDA OK, recruiting transplant centers, paying them, making and shipping product ...
I hope DORB can do all this. The need for a gastro GVHD tx is acute. Funds from the compassionate use deals lately entered into might help - or are they going to be negligible? Alternatively, or additionally, might the NIH P2 trial in GVHD prophylaxis provide the way forward?
As a gamble, I agree it seems like the Clark strategy of waiting (and waiting and waiting) makes much more sense on DORB than it does on RPRX. (It's OK Clark, just teasing. There's a respectable argument for waiting on RPRX, too, and so far (as the jumper from the Empire State says)it has beaten the hold strategy. I just don't buy it on balance.)
June 30 , 2008
DOR BioPharma Announces Collaboration with Numoda Corporation for the Execution of Confirmatory, Phase 3 Clinical Trial of orBec®
Ewing, NJ – June 30, 2008 – DOR BioPharma, Inc. (OTCBB: DORB) (“DOR” or the “Company”), a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that it has entered into a collaboration with Numoda Corporation (Numoda), experts in rapid information turnaround, for the execution of its upcoming confirmatory, Phase 3 clinical trial of orBec® for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD).
Collaborating with Numoda will allow DOR to take full advantage of a comprehensive scope of services including using their robust industry benchmarking capabilities to develop an accurate operational and financial plan including the use of an extensive and proprietary management and oversight capabilities process. Most importantly, Numoda’s highly accelerated and efficient data lock at the end of the clinical trial expedites completion of the study while also increasing quality. Barring any unforeseen modifications to the Phase 3 clinical program, Numoda will guarantee the agreed clinical trial budget against cost overruns. As part of the collaboration, Numoda will also take an equity position in DOR common stock in exchange for a portion of its services in connection with the conduct of DOR’s upcoming confirmatory Phase 3 clinical trial. Working with Numoda, DOR will be also able to take full advantage of early reporting of results to potential licensing partners and others.
“It is exciting to be working with DOR on this vital clinical project that has the potential to offer a logical answer to the urgent unmet medical need of GI GVHD,” said Christopher Mather , Senior Vice President of Numoda. “We look forward to working with DOR’s clinical, regulatory and medical team to bring this product to the patients who so desperately need a therapeutic option.”
“We are very pleased to be working with Numoda,” said Christopher J. Schaber, PhD, President and CEO of DOR. “Numoda is extremely well-regarded in the industry. We believe that Numoda will perfectly supplement our executive management team, including our esteemed Medical Advisory Board, by providing operational, financial and logistical services, as well as unparalleled clinical trial norms through reporting of information that will be essential to the conduct of a successful Phase 3 clinical study. There will be proactive management of the trial in a live format ensuring that the trial will be conducted efficiently and in a high-quality manner.”
Dr. Schaber added, “We are also pleased with Numoda’s willingness to invest in our Company as we move into this very important program.”
AI
