Re: Exposure in Motley Fool....
in response to
by
posted on
Oct 08, 2019 07:04PM
narmac - I found masila's notes from the 2015 AGM, 30 Sept 2015 in the Link Library. Below are the 2 relivant paragraphs. These notes are on page 9 of the Link Library and dated 05 Oct 2015.
Focus will be on patients with low HDL that have diabetes – very sick patients.. We’re looking for events. I can’t tell you exactly how much it will cost and exactly how many patients will be in there, but I can tell you that this trial will run until we have over 250 events (death, heart attacks, strokes) and we really want to see most events in the placebo group. If the statistics hold true to what we’ve seen in the last three consecutive trials, we should do very well. We’re not looking for 70% RRR – we’re looking for 25-30%. Some of these patients will be brought to us from China – 250 of them as part of our Chinese deal. There may be some additional deals like that, that will bring additional patients to the trial.
(15 minutes into the presentation) Around the world, agencies have really tightened up on their description of MACE because of previous abuse by some pharmas. For example, 8 point MACE (I coughed and it’s regarded as a severe event). Now it’s 3 points only – Death, Heart Attack, Stroke. We’re looking for 250 of those. We’ve put in parameters that we believe will lead to higher number of events – this is a really sick population and they will have higher events. Our estimate is that over an average period of 18 months on dosing, we should see 12-15% severe adverse events. That works out to about 2½ years.
– BETonMACE will likely go to the middle of 2018. If we have a 20% event rate, it will be a lot shorter and a lot cheaper, but if it takes longer, we’ll just ride it out.
I don't recall seeing or hearing what you remember but I do remember seeing this presentation and reading the great discussion on this board. I was not posting at the time.
From our dicussion the other day about statistical significants I found this paragraph below in those notes as well.
A 5 different companies were negotiating with us. Went with Hepalink because they moved very fast and secondly because they’re a global company, not a fly by night outfit. They make 70% of the world’s heparin. They make it for Sanofi and Novartis, but in China, they are their own distributors. They have a very good network because of the way things work in China. 6% royalty. Also put in sales milestones – 50% of the deal. They remain with Resverlogix. The royalties flow through to Zenith. Over 15 years, we expect over $400M. May be double that. It will be a very good deal. 15 years from first commercial sale in China. Also, Hepalink provides at their expense 250 patients for the trial, saving us $3-4M in costs. Also they agreed to pay for all development, regulatory, move forward filing costs (could be +$10M). Very exciting deal.
(This is an on the side comment but I believe there have only been 100 patients recruited in China for BETonMACE. This could be where I'm thinking that there could be, may be another 150 patients that could round out this trial. Bear says not likely and I just don't know.)
As far as I know there are still 4 or 5 companies that continue to engage in discussions with RVX. If there is anything worth pursuing when we here and see the full data presented on Nov 16 it would not surprise me at all to see either an offer to be bought out or some type of partnering agreement shortly thereafter.
Bolding is mine.
tada