Replies to post #370505 on Innovation Pharmaceuticals Inc (IPIX)

[petemantx]

So we get top line results sometime around the end of the month to very early Sept and let's assume as many of us believe that we get excellent results.

Now according to your time line, how long do you think it will take to sign a licensing arrangement, design a P3 protocol, and get an EUA application submitted?

I would assume 2-3 months minimum. More likely end of year at best. Then add another 2-3 months to get P3 actually going as we saw with the current P2 B trial.

And yet NIH director today said delta variant cases would soon top 200,000 per DAY.

That is a lot of people to leave in the lurch when you have data showing that a treatment is already available now to keep them from dying.

Seems that means little to bureaucrats that don't want to stop people dying at the risk of changing their sacred time lines and protocols. As usual, fast track simply BS.

I think govt should immediately give IPIX a $100MM advance or grant to get Brilacidin into mass production immediately and issue an immediate EUA. They wasted tens of billions on worthless BP vac drugs that showed no ability or trial results to be effective, so why would $100MM to a shown capable treatment be considered reckless?

To be honest, I would like to have seen who actually did the trial data for the BP POS drugs that were given immediate OK to proceed as IMO it was the BPs own labs and their results sure didn't match up with reality. I am talking about the seemingly 100% of failed CV drugs in actual trials that tanked after BPs given ungodly amounts to have brought this repurposed crap to the light of day.

[Minnesinger]

I agree, though I would amend your sequence...

as follows:

- Topline Data
- Partnership/licensing
- Breakthrough Therapy designation application submitted
- BTD granted
- P3 initiated
- P3 interim readout
- EUA application submitted

There hasn't been much discussion on BTD here. Likely a consequence of, as you say, cart-before-horse thinking. However, with strong P2 results, I'm thinking we're a shoo-in for BTD. Per the FDA:

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

...

Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

Given our involvement with CTAP from the beginning, followed by Fast Track, BTD seems the next likely step in the process. That is, of course, if P2 results warrant accelerated development. Fingers crossed.

[CallMeCrazy]

Leo is in the driver's seat and he knows it. I believe Leo has been engaged in talks with various BP for quite some time because part of the EUA process is to show how you plan to manufacture and distribute the authorized drug and the U.S. Gov't has a lot say in these areas.

When a company has an asset that others in the industry can easily value in the billion$...funding is not a problem.

If BP is any example, Gilead did a P-2, then obtained EUAs from around the world and did a P-3 LAST. They made nearly $5B before they completed a P-3 and gained FDA approval. (Business 101)

Having or applying for the EUA is what puts Leo in the drivers seat. Potential partners are attracted to the EUA quick-cash and Leo is probably negotiating with several BP entities.

I found your post a bit confusing in that I could not tell if you're advocating using the "authorization" pathway or the drug "approval" pathway. These are two different pathways and you seem to have created a hybrid of the two.

What is "putting the cart before the horse" is designing a P-3, which is part of the drug "approval process", before applying for an EUA, which is part of the "authorization process".

These are two TOTALLY different pathways and I don't think any BP, at the moment, is interested in partnering with IPIX for possible long-term profits, years down the road and after dozens, if not hundreds, of competing products have entered the market.

We are years away from Brilacidin gaining "approval", as a broad-spectrum antiviral. But B-COVID could be months away from making billion$ as an "authorized" COVID therapeutic.

For Leo, this has to be the biggest no-brainer of his career.

Response in reply to:

I think it's putting the cart before the horse to talk about EUA before partnership. It makes zero sense to me to have an EUA that cannot be acted upon (lack of funding and lack of infrastructure to do anything on scale). I would expect the following sequence of events:

- Topline Data
- Partnership/licensing
- Phase III designed
- EUA application submitted

[PJ007]

You forgot to mention large government grant!!!!!

[shazamm]

ROMAD, there’s a lot of cart before the horse talk being tossed around here, in addition to eua, and I wish it would stop. I fear the way too early big $ talk BAM! As the non-stock folks say in my world….I don’t see an IPIX stock button on the POS machine at Macy’s & Target!