I bet you have answers to those questions! So B-OM for ipix is now getting crushed by at least two om treatments. Though more and better ones seem to be popping up by the hour. We are in trouble.
I just read the details of the product and it hase been available on the market for years.
I sent it to Leo before looking into it and Leo commented back (Our CEO is pretty bright):
Obviously, if this was "effective" in treating OM it would be unethical for the hospital or FDA to allow placebo in an SOM trial. I don't think I need to say any more than that.
The ProThelialTM is the only FDA-cleared prescription medical device containing polymerized crosslinked sucralfate. As a full management oncology support product, ProThelialTM has been associated with both the rapid reversal/elimination and complete prevention of oral mucositis. It was cleared by the FDA in August 2013, and has produced results heretofore unassociated with any mucositis intervention.
On November 8th 2014, an agreement was signed with Walgreens, wherein it will function as one of four Specialty Pharmacies to provide healthcare professionals and mucositis patients, immediate access to ProThelialTM. The main goal of this partnership is to increase visibility and thereby accessibility of ProThelialTM to oncologists in the US, and to ensure that every mucositis patient has access to ProThelialTM.