Ann: Clarification Announcement, page-382

Hi Hesh,

If you watch the Proactive Investors interview with LC this answers some questions



When I replied you the other day, this is what I was going off from the ANN. I guess the “no material difference to the cost of the trial AS BUDGETED” may be the key thing here - the supply agreement with Merck was only ANN’d in March - so cost of the drug was already factored in to the trial budget (n=30 patients). I apologise if I got this wrong, but taking it on face value.

In the interview with LC she refers to obtaining Pembrolizumab “off the shelf expeditiously” & then she did say “buy off the shelf”, so this ties in with direct reimbursement of Hospital pharmacies. So via hospital pharmacies (who are also part of the clinical trial team).

The HREC approval & first trial site opened in Australia came through earlier than expected & more to open both here & in the USA.

LC stated they wanted to expedite the trial as quickly as possible & we are able to access supply. So as @Taureanbull has already said in another post, I think that this does give us a clue that maybe supply by the agreement maybe wouldn’t be quick enough for trial commencement.

Merck had a huge European Approval on 29/4/22 & as I said last week (& others have posted as well), this could have impacted on supply chains & Approval for the trial going through faster than anticipated. The supply agreement was cancelled on 2/5/22, 2 days after Merck’s Big EU Announcement.

Note: I have already posted a link to this & PBS approval information last week on Keytruda. Merck (MSD) Australia’s website has more information also.

Either way, the trial is going ahead ahead of schedule & LC did state they have a couple more lines of committees to go through (Site specific Ethics etc). It looks like we are paying for supply, but that was already factored into the trial budget, prior to the supply agreement ANN.

So be it & I guess on that one you may need to ask LC on drug costing per patient for the trial (also taking into consideration R&D Rebate). I don’t think it is going to make a big dent in our ~$100 million bank balance & time is of the essence, LC made that very clear. I think that we will see a massive interest in this trial from patients, because the cost to them with therapies not being on the PBS is huge.

We have another 2 trials that will be in combination with Pembrolizumab also.

This is just in relation to your questions, but much more of an update on our pipeline in that interview, if you haven’t had the chance to watch it yet.

GLTAH