Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

So either I guessed this correctly or I read it before and forgot about it:
"Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course)."
Either way it's good that you dug it out.

You and PP (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145695966) have both commented on the willingness of doctors to prescribe medications for off-label indications. And I read PP's comment that "Trials using HNC subjects happens to be the easiest (limited treatment time plus very high incidence of SOM) route to approval" as an explanation for why that inidication was selected for the trial(s). I hope he doesn't mind that I respond to both posts here.

It sounds as if you both (along with the Company) hope that the drug will be approved for use in the treatment of OM in HNC patients who experience the disease, but that it will in practice be prescribed for "all patients as soon as starting chemoradiation and continue until its completion" (per the Company, which appeared to be referencing HNC patients only...that doesn't expand the market expectation much), obviously prior to contracting OM.

"should Brilacidin oral rinse gain regulatory approval" the above sounds like a fine hope. But....
I noticed the parenthesized phrase in your statement:
"this does not prevent off-label Rx by docs (only marketing of by Sales Reps)"
Off-label usage would also be prohibited from being marketed by the Company itself, right? (Forgive me if that's obvious.) So significant off-label use for the described purpose would result from basically word-of-mouth communications in the medical community if I'm tracking the process correctly.
PP said "Also, after approval nothing prevents attending physicians from prescribing the drug off label to treat OM occurring with other than HNC subjcets."

Don't know what sources to believe but it sounds like some people think that 70,000 people in the US get HNC annually and 1,900,000 people in the US get OM every year (at a lower incidence rate for most cancers, so it makes sense that that is materially less than the number of patients who COULD be prescribed "as soon as starting chemoradiation and continue until its completion").


Is it likely that the FDA would allow an off-label use while simultaneously having an awareness that the prescriptions for that off-label use were being issued at the rate that is many multiples of that which were being issued for the approved indication, generating significant revenues to the manufacturer? Are there examples of that happening with other drugs prescribed off-label to prevent the occurrence of a disease?