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gameangler,

Exactly, CVRs are a way of recognising potential when the outcome isn't certain. If they had simply issued extra shares to Amryt holders and Filsuvez had gone on to fail then that wouldn't have been fair to Aegerion holders. I understand where you're coming from joxer, but I think in these particular circumstances CVRs work well. Also don't forget that if Filsuvez is approved then Amryt receive that Priority Voucher which based on the last one to hit the market is probably worth around £100m - all purely down to Filsuvez.

corr antiviral

TF - my point was that if labelling for the Pfizer antivial is the same as Merck's then the vast majority of the population won't be eligible to receive it and so they can't rely on Paxlovid as a substitution for vaccination.

TF

Possibly but these antivirals aren't intended to replace vaccines - worth looking at the labelling for the UK's approval of Molnupiravir this week-

'Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.'

So if you don't have an additional risk factor, you won't be receiving Molnupiravir and I suspect the same will apply to Pfizer's antiviral. Think the cost of Molnupiravir is going to be somewhere around $700 per course versus abot $20 for a vaccine.

For the first time now it seems that there are effective therapeutics for Covid that cover the vast majority of the population and that could mean that human challenge trials will be a viable option for the clinical development of vaccines. If so that would greatly cut reduce timescales and costs.

joxer,

The reasoning behind it was that Amryt paid for Aegerion with Amryt stock. However, the equity was issued at a price that obviously was much lower than if Filsuvez had already been approved by the FDA/EMA - in other words, the valuation didn't reflect the potential value of Filsuvez as a commercial, approved product. In effect, this meant that having funded the development of the product, original Amryt shareholders faced losing a share of the potential to Aegerion shareholders and the CVRs were a way of compensating original Amryt holders for this loss of potential. The CVRs ensured the structure of the deal for the Aegerion acquisition was fair to Amryt holders.

If they simply reinvested the same cash in the business then the whole of the new enlarged shareholder base (including Aegerion holders) would benefit.

Joe Wiley:-

"We're a biotech that makes money, we're growing like a weed"

Not too many of those around on AIM.

Chester - for all we know they may well already have ethics approval. It's not something that would usually be announced via RNS.

Crumbs - if you want to perfect your ramping skills then perhaps you should learn to draw some rockets and while you're at it, create some rampy slogans to match. :)

.......closely followed by EMA decision

https://www.irishtimes.com/business/health-pharma/irish-pharma-group-amryt-reports-15-revenue-growth-for-third-quarter-1.4718161

Crumbs,

I'm hopeful that Scancell will issue an RNS when the last patient has been dosed in part 1 of the trial - ie. when all patients have received both SCOV1 jabs

From your 14.38:-

'So maybe we could see some acceptance of ALL views.' ....................................

Apparently not.

Surely when you cut through all the angst, the point is that Redmile are currently holding nearly 250m shares in Scancell in addition to the CLNs. They'll have an exit plan and the fact that they are continuing to hold that stock, have extended the term of the CLNs and bought Lindy Durrant's stock suggests that they clearly must believe that exit is still on the cards. That will be sufficient for most longs here - those looking for shorter term trades will obviously be looking to exploit (and possibly help along) dips in sentiment - isn't it as simple as that?

Ray/Crumbs

Yes agree with both of your last posts.

I'm really hoping they use Covidity to validate the new Avidimab enhanced version of ImmunoBody and use the data to optimise the design of a decent sized, well powered new SCIB1+ or a SCIB2 trial. Time will tell and of course there could be other factors that we're completely unaware of at play here.

Clare,

Good to hear from you, hope you are well and all is good your end.

Interesting find and a sign of the way things are heading when it comes to covid clinical trials, thanks for posting.

Crumbs,

The problem is that the current study is designed to offer patients who are about to be prescribed Keytruda the chance to join the trial, so recruitment completely depends on patients being prescribed Keytruda as a monotherapy in the first place. When the trial was set up, that was fine because Keytruda was a SOC treatment for patients in this setting, but things have moved on and now the SOC is a combination of Yervoy and a PD-1 , so it's hard to see where they're going to find patients from to fill the study no matter what the delivery method.

Ivan,

Re. SCIB1, I agree, it's been a nightmare and beyond frustrating but I think continuing with the study will only add to that frustration as we wait and wait and wait for patients to be recruited and just how useful will the data be at the end of it?

I'm not sure how far they've got with preclinical development of SCIB1+ , they certainly would need to manufacture new supplies and go through all the usual development steps. Having said that, I assume they could use original SCIB1 data for evidence of safety and go straight into phase II studies, perhaps with a quick safety run-in. Who knows, Scancell have preclinical evidence that ImmunoBody works with CTLA4 inhibitors as well as PD-1 so perhaps the ideal setting for a trial would be with the standard of care therapy ie. a combination of Yervoy, Keytruda (or Opdivo) and SCIB1 - at least then you'd have data relating to the commercial setting.

I don't think anyone here is invested and holding for SCIB1 trial results - it's something that's just rumbling in the background and I think resources are best spent elsewhere. Just my opinion of course and I know many will think otherwise.

Johnny,

Interesting and well spotted

You didn't beleive they had the technical expertise to run a simple phase I trial so it's hardly surprising that you think they're biting off more than they can chew.

Thanks Ray, I'm sure many won't!

Ivy,

I have a slightly different view re. SCIB1. As you know, I have always had an issue with the scaled back version of the current trial and was delighted to read the comments in the annual report today.

I believe it would be a complete waste of money to carry on funding a trial for a product and delivery method that has now been superseded and that is likely to have real issues with recruitment. It's not just the HLA restrictions, but a much bigger problem IMO is the fact that standard first line treatment for patients in this setting isn't Keytruda alone. It's either a combination of a PD-1 inhibitor plus Yervoy (CTLA4 checkpoint inhibitor) or a BRAF inhibitor for those with BRAF positive tumours . So if HLA restrictions mean that you're recruitment pool is reduced to only 40% of the population and then the standard treatment for the rest isn't Keytruda alone, you have to ask why you would continue when you have a superior product in the pipeline that can reach a much wider population?

On top of that, Scancell now can use Covidity to validate the ImmnoBody platform. So I really hope they take action now to halt the current trial before recruitment of any patients and concentrate on SCIB1+ with Avidimab.

It'll be really interesting to see how they handle this - the easy way would be to plough on regardless as many AIM baby bios would do, but as bios grow up, sometimes they have to take tough strategic decisions and I hope they'll be bold enough to follow that path.

pistol7 - thanks for that and well spotted!