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Re: TheHound post# 108711

Friday, 06/19/2015 9:12:27 AM

Friday, June 19, 2015 9:12:27 AM

Post# of 405194
What makes you think that?
MDA would have had access to the eligibility criteria before this 12/22/14 statement was released, wouldn't you think?
"Cellceutix has received Institutional Review Board (IRB) approval to initiate its Phase 2 study of Brilacidin-OM, the Company’s novel oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer. Study sites identified in the U.S. include MD Anderson Cancer Center at the University of Texas."

ClinicalTrials.gov Identifier:
NCT02324335
First received: December 17, 2014


BTW, here's the flip side, all of which I should have read earlier:
Inclusion Criteria (excerpts):
# Have recently-diagnosed (within previous 3 months), pathologically-confirmed, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx, that will be treated with CRT therapy as first line treatment; scans (CAT, PET, and/or MRI) obtained within 45 days prior to consenting (screening) can be used to determine the patient's eligibility
# Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose =55 Gy and =72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate) with each site receiving = 55 Gy [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]
# Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)


It's morally wrong to allow a sucker to keep his money.......Cuthbert J. Twillie

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