Saturday, November 28, 2020 11:36:43 AM
Hah, good point. I truly find it hard to believe that you believe the SAEs that were not rated as related to brilacidin were significantly more than placebo. All the SAEs were related to the disease and the chemoradiation to treat the disease.
Nausea: 1/30 placebo, 2/29 brilacidin. Are you really trying to argue that brilacidin somehow makes nausea of chemotherapy worse due to a non-significant increase in 1 subject out of 30?
Hyperglycemia: 0/30 placebo, 1/29 brilacidin
Hypoglycemia: 0/30 placebo, 1/29 brilacidin
Are you really trying to argue that brilacidin (which does not signifcantly enter systemic circulation) causes serious a change in blood sugar to be both too high and too low at the same time and this is a major concern for its continued development??
Really?
If you think a 1 subject out of 30 difference in SAEs is significant, then I guess you must be really concerned that placebo causes vomiting and oral pain, since those occurred in 1/30 subjects on placebo, and 0/29 on brilacidin.
Come on, none of the incidences of SAEs are different with brilacidin versus placebo. None of the SAEs were thought to be related to brilacidin. There is no safety signal of any concern from B in OM. There is no plausible mechanism for brilacidin to cause any of the SAEs (which are all known SAEs from chemoradiation or the disease itself).
LR has linked to the many reports of non-significant systemic absorption of brilacidin through oral or gut mucosa.
Safety of topical or oral/GI brilacidin is simply not an issue based on the data we have seen so far.
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