Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

While much has been discussed about the meaning of QIDP, and much of it accurate, there is still the elephant in the room no one has touched on in two days of posting: breakthrough therapy designation. BTD will be applied if the FDA sees sufficient data which would include any or all of the following

A new drug classification
Efficacy or increased efficacy over current options
Decreased dose duration
Decreased AEs and counter indications/increased safety

BTD would mean a phase 3 trial with rolling review and accelerated NDA processing. Rolling review would mean the trial can be declared complete before full enrollment for the trial is reached. That would mean an immediate NDA filing followed by market approval under phase 4.

With a big pharma partner the likelihood of a BTD increases as the FDA will also look at a company's ability to quickly ramp up manufacturing and marketing/distribution.

Some of what is possible with bottom line results following discussion with the FDA include accelerated review, fast-track, BTD, rolling review during trial and a partner.

I doubt that $5 prices in the bottom line. To echo KarinCA's words, probably (much more likely) double-digits.