Replies to post #250154 on Innovation Pharmaceuticals Inc (IPIX)

[Minnesinger]

Thoughtful post. Thanks. Perhaps a naive question:

Wouldn't the potential concerns you pose be more applicable at the New Drug Application stage, rather than BTD?

[loanranger]

"If I'm the FDA, given the 7/17 news, here's what I'd want to know:
- results of accelerated and long-term stability testing of B granules packaged in the selected sachet substrate, meaning what do the sachet substrate and its contents do to each other if they're sitting on a FedEx trailer in Arizona for 36 hours at 150 degree ambient, or a Seattle warehouse in high humidity for 26 weeks
- what is the air permeability rating of the substrate, and does B efficacy degrade in extended air exposure
- does the selected substrate have any history of delamination, discoloration, or other adverse reactions
- what happens if Brilacidin is mixed into particularly hard or soft chlorinated tap water, instead of USP water
- what happens if some idiot drunk and blind with pain mixes up 9mg/ml instead of 3, and swishes and swallows it"

I'm sure they would like to know all of that stuff at some point, but they don't need it to make the BTD decision.

https://image1.slideserve.com/2935477/request-for-breakthrough-therapy-designation-n.jpg

I couldn't find a sample BTD Request. Maybe I didn't look hard enough because I spent my time looking for a Breakthrough Designation Letter.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761025Orig1s000Admincorres.pdf
Buried on p.106 of 126


The Grant does not specify method of delivery. I get the sense from that and the requirements of the request that it is the drug itself that is the focus of the BTD. (As they make clear, a BTD is not an approval.) Everything I've seen suggests that for BTD purposes a submission based on the HISTORICAL results won't be discarded because the future use of a sachet isn't consistent with the pharmacist's jug o'powder/Poland Spring/Waring Blender dispensing technique that was used for the trials and that the sponsor used for the designation request. Now if the Company chose to wait for the sachet to be developed even though the FDA appears not to give a shit about the method of delivery, you would have to ask them to explain why they did that. Was it James Carville who said "It's the drug, stupid."?

I think it's the drug.

[To infinity and beyond!]

huh? BTD time frame has come and gone already 10 days ago and the only ones who cannot see it are pretending there is some agreement that prohibits disclosure that they got it.

Allows announcing that they applied, but prohibits announcing that they were given BTD.

That just seems so likely- not.