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loanranger

03/13/19 8:47 PM

#258141 RE: PlentyParanoid #258139

"What, by the way, means potential gamble?"
You'll have to ask the person I quoted.

"It is common parlance to refer a drug accepted by FDA into phase 3 as phase 3 drug."
Is it?
"Tell me what else it could be?"
A drug that has completed Phase 2 testing.

"I see your point about of making too much out of acceptance into phase 3."
You see a point that I never made.

Here's what we were told by the Company and only the Company 3 months ago:
"Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen."

The very next sentence was:
"Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment."


I don't have to tell you what happened to the last two Phase 2 clinical trials that suffered from delays of information from the Company, information that wasn't provided as expected, do I? Neither resulted in a Phase 3 trial nor can they be called Phase 3 products , can they?