Open Orphan Share Discussion Threads

[mfhmfh] 11/1/2021 10:30

children receive a nasal spray for the 'flu vaccine unlike adults who receive injections only.

this could be used to immunise children globally.

huge potential IMHO especially as a single dose.

[chopsy] 11/1/2021 10:29

Many years ago I used to subscribe to that tip sheet. They did advise hold off for a bit, don't buy on any spike, let the price settle, buy later in the day or even a few days later, or on a weak day. Can't do any harm to be on their list, though no big response so far. Nor to the RNS, but we are used to that. Up at these elevated heights we will have to wait for a blockbuster to see a mega spike, e.g. to 70p.

[supernumerary] 11/1/2021 10:26

It also looks like a 2-shot vaccine. I'm not convinced that there's a very meaningful distinction between the two.

[1gw] 11/1/2021 10:09

Going back to the July press release, the study includes a surrogate viral challenge:

"Study will include second dose as surrogate viral challenge at Day 28"

So this does to me look quite like a challenge study. They give a weakened form of the virus (very slow replication) at the start as an intended vaccine. This should not give anyone "proper" Covid-19 but is intended to produce an immune response to protect against the actual (full-strength) virus.

They then give a second dose at day 28. Since the trial is of a single-dose vaccine, this second dose is nothing to do with improving the efficacy of the vaccine (as happens with 2-dose vaccines such as the 3 approved in the UK so far), it appears to be there purely to simulate someone catching (a very mild form of) the virus after having been vaccinated.

So doesn't that second dose look awfully like a "mild" Covid-19 challenge study?

[pierre oreilly] 11/1/2021 09:54

There are a few sets of data flying around orph.Orph have said or strongly implied- the genomic database revenue will be shared with patient groups- the disease progression database is 100% orph's and will be monetised to wearables and anywhere else- the data from this P1 study is a new one. Not sure orph have much P1 data or what it's worth or who owns it. Anyone?

[lako42] 11/1/2021 09:53

I make it 8 bits of news released since our 30p foray in October.

SP needs to play catchup

[nigeldoug1] 11/1/2021 09:42

Do they have the proprietary rights to the data or is it the customers?

[wreckage] 11/1/2021 09:38

Just think of all the monitoring data that will be amassed during this study. 1 Specific to Covid 102 Gathered under strict rules and control 3 Outcome known at the end of the trial. 4 Data on individuals taking part, gathered before during and after the administration of the virusAll this is saleable

[mark10101] 11/1/2021 09:34

Rathean/1gw, certainly on the same page as you guys, the World leader in virology, soon to have the only human COVID challenge study in the world and can still be bought for peanuts, exciting times ahead for ORPH.

[molatovkid] 11/1/2021 09:32

I did wonder if Cathal could buy Codagenix (or a stake in it) and this is what we are leading up to.

However, Codagenix appear to be a private company but have billionaire backing.

[rathean] 11/1/2021 09:19

Agreed, it's a big flag waving exercise to let all pharma know it has the capability at its soon to be announced expanded capacity to run c19 trials.This thing is not going away, every year a new tweaked c19 jab will need testing and producing to give out to the most vulnerable.

[1gw] 11/1/2021 08:24

ORPH are making a big thing of this Codagenix trial, and their press releases read like the drug developer rather than the "picks and shovels" provider:

they announced when they got the contract (July);
they announced MHRA approval (December); and
today they have announced first dosing.

So I think ORPH are signalling that this is not a run-of-the-mill contract for them. That could be because it uses the actual (attenuated) Covid19 virus - and so maybe they see it as ethically a first step on the way to a challenge trial. Or it could be because they don't usually get to use their quarantine clinic for a full phase 1 study and so want to tout their capability and availability to do this with live virus trials - perhaps uses their beds for longer than a typical challenge study would and so means more revenue.

In any event, I think ORPH see this as significant.

[kpe] 11/1/2021 08:09

Shovels and pick axes come to mind.

[pierre oreilly] 11/1/2021 07:53

Yes, we get paid for the trials. That is our cro low risk business. We won't go bust if this vaccine fails any phases over the next few years like many drug Dev companies will.Anyone invested here hoping for orph to own a vaccine of some sort under development will be disappointed. At least until imutex gets floated, then we could well do.We'll likely get phase 2 and a challenge study from codagenix if it passed phase 1 and they like orph's services. That's how we make it money, not via extremely high risk drug development.

[sh0wmethemoney] 11/1/2021 07:49

No this is for the safety trial of a P1 trial.

[malcolmmm] 11/1/2021 07:46

Does it not confirm Challange studies are acceptable

[molatovkid] 11/1/2021 07:37

'This is big! Single dose Intranasal....if it works its a gamechanger'

For Codagenix yes, Orph not so much. If we don't own the business or have a share in it, sounds like we get paid for the trials and that's it. At least we get paid whatever happens.

[adorling] 11/1/2021 07:32

Great PR for our world class and world leading Company.

[garth] 11/1/2021 07:30

Timberwolf,

Dosed, not injected. And that is part of the big deal.

Second gen vaccines - CF has been talking about the second wave offering significant benefits over this initial wave.

:0)

G.

[matheus7777] 11/1/2021 07:29

Presumably could be delivered en masse to the population for self administration which would be vastly quicker than going somewhere for a jab whilst having to manage social distancing from others

[shearluc] 11/1/2021 07:21

This is big! Single dose Intranasal....if it works its a gamechanger

[judijudi] 11/1/2021 07:17

Let’s hope the volunteers stay safe and stay well

[timberwolf3] 11/1/2021 07:10

RNS out - Codagenix trial underway first volunteer injected

[sambuca] 10/1/2021 23:15

The vaccine is not effective until around 14 days after it has been given. It does not prevent you getting the virus it only diminishes the symptoms, after vaccination you still have to use the usual precautions of wearing a mask etc as you can still be a carrier and infect others though not showing symptoms.
My wife had the 1st shot of the Pfizer vaccine on Wednesday, problem is she has no record that she has had it no date for the second dose, though the doctor giving it said he had little faith in the second dose being given as late as 12 weeks after the 1st dose.

Sam