Sharewise Presentation 22/7/24, page-136

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Mangoman605

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30/07/24

18:48

Post #: 74988449
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Originally posted by ceviche: ↑

Thanks for the post.
As to where we are at: PR in quotes..
On dosage PR said to Kohler"So we've done that now, we've got that document in front of the FDA, we're just waiting for them to give us clearance to go ahead with that dose""--so it IS the FDA who give clearance.... clearance had not been established, independently.

"So, recruitment is getting those 400 people to sign consent forms and have them treated with the drug, but each patient has to be followed up for 12 months because also during that intervening period, we also did a phase two study on the two milligram per kilogram dose".
" getting " -is in the future, has not happened yet.

"We hope that we'll be able to execute the recruitment of that phase three clinical trial within 10 months","but each patient has to be followed up for 12 months because also during that intervening period, we also did a phase two study on the two milligram per kilogram dose. "
It had been unclear whether there is another 12 months after the 10? -- but this clinches it for me "allowing us to do this 400-patient trial."

From the discussion on labeling, it appears that PR wants to get the "good news"about other favourable effects so he is looking for the extra 12 months."so it pushes the timeline out to about two years"
-- when did he first realize that? why was it not made explicit?

On capital "being able to fund it via partnerships as opposed to going back to investors and offering them equity. Given the low share price, our preference is not to go back to the market, but we have to do what we have to do to get the money to keep the program running." welcome if believable.

So i think it is clear we are at least two years plus whatever FDA requires of us in their immediate response to us that we are waiting on, before we get a submission to them on what we want on a label, and they do their thing on what that is allowed to be. Mid 2027?

I don't know what others think, but i think we need to do a deal, rather than a CR.

Expand

We need to do a deal, but how much do we give
away to get it? What is everyone’s bottom limit?
20% royalty?
15% royalty?
10% royalty?
8% royalty?
Remember, whatever royalty we receive, is a
large part of what sort of potential blockbuster
we have. $2500 sounds pretty good. 10% or
$250 doesn’t sound so good. PAR has to
purchase raw material from Bene and than
reformulate and package etc., etc.,.

Upfront or milestone payments will be mainly
just to get us through the trials and to market.

While on the subject of trials,( I may have
missed it), what happened to 003 confirmatory
trial?

PAR Price at posting: 26.0¢ Sentiment: Hold Disclosure: Held
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Sharewise Presentation 22/7/24, page-136

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Sharewise Presentation 22/7/24, page-136

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