Wednesday, December 26, 2018 11:06:00 AM
A quandary.
I have a more practical question:
As I understand it the market for B-OM was defined in the ODD application as Head and Neck cancer patients. IIRC there are (or were when i was looking at it) about 70,000 of those a year in the US and a REALLY LARGE percentage of those developed OM.
One the other hand "DelveInsight estimates that approximately 1.9 Million patients in the United States were diagnosed with Oral Mucositis in 2016." (No idea how reliable they are.)
https://www.delveinsight.com/blog/meeting-the-unmet-need-for-oral-mucositis/
Another source says tis:
"Mucositis is an inflammatory process that affects the mucous membranes of the oral cavity and gastrointestinal tract. ONS PEP resources focus on oral mucositis, which is estimated to occur in about 40% of patients secondary to chemotherapy and almost 100% of those receiving radiation for head and neck cancer. Approximately 80% of those undergoing hematopoietic stem cell transplantation will experience some level of oral mucositis. Oral mucositis can range in degree from mild changes in sensation to severe oral pain, infection, and ulcerative bleeding lesions. As a result of oral mucositis, patients can also experience anorexia, dehydration, weight loss, and malnutrition because of difficulty eating and drinking.
Oral mucositis is a dose-limiting side effect of cancer treatment, with more than one-third of patients discontinuing treatment because of the condition. Oral mucositis can be costly as well, necessitating hospitalization in 62% and tube feedings in 70% of patients with this symptom."
https://www.ons.org/pep/mucositis
The point is that A LOT of people get OM after being treated in standard ways for several different varieties of a tragically widespread disease.
I may be mistaken but it seems to me that the major benefit of OM is in the prevention versus the treatment phase...that's what appears to distinguish it. And the simplicity of swish and spit.
Does the FDA approve drugs for the prevention of a disease when the patient does not yet have the disease? I guess the existence of vaccines shows that they do. Why isn't the target market for B-OM ALL patients who are about to undergo the treatments that are known to cause it? Would that be constrained by safety issues or cost (something that I don't think the FDA cares much about)?
But can it core A apple?
Yes Ralph, of course it can core A apple.
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