Open Orphan Share Discussion Threads

[chopsy] 14/12/2020 10:38

Infected, snort.

[supernumerary] 14/12/2020 09:06

The volunteers won't be in bed I don't suppose - they're young and healthy after all - but I believe they will be resident. How else are they supposed to keep careful watch on them?

And they are being injected with a live albeit attenuated virus, and one that's not been seen out in the wild before. It seems obvious to me they need a secure facility.

[troutisout] 14/12/2020 08:52

Jeez, last week he was saying that the Australian vaccine (in phase 1) would have been done cheaper and quicker in a challenge study and now he is saying this.
The reason it has to be done in an isolation unit is they are using the whole virus (albeit a weakened version).

[pierre oreilly] 14/12/2020 08:50

9373, yeah, agree that could be a possibility.However, it's massive overkill using a secure facility for something not requiring that security, especially at a time of such high demand and low supply of such secure clinics.I know the facility can be run in different modes, sometimes totally secure and others with little security. So perhaps that's what's happening here. We are really commenting in the dark. Surely someone reading must be in the buzz and could comment?

[troutisout] 14/12/2020 08:39

1gw,
Exactly.

[pierre oreilly] 14/12/2020 08:38

9370, 1g, no idea. We need someone in the bizz to comment.But afaiia, phase ,1 for most drugs isn't done in a secure facility. No reason. There are no infections involved.

[1gw] 14/12/2020 08:37

Pierre - my question was whether CF has been assuming this study would go ahead and counting beds booked for this study when he reports that the clinic is fully booked until the end of next year - on the basis that he saw very little risk of it not going ahead. I don't think there's any chance anyone is "booted out" of the clinic, or other studies are delayed, because of this. If beds are needed for this study I think they have already been committed, and possibly a reservation fee paid.

[troutisout] 14/12/2020 08:34

Pierre showing great insight and knowledge of the subject, LOL!

[pierre oreilly] 14/12/2020 08:33

1g, Yeah, that's a possibility.But would they delay pre booked challenge study, which decides need security, for a phase one which likely, or usually, doesn't? Doesn't make sense to me.One thing is certain, the rns doesn't state at all that the beds will be occupied for this study.

[1gw] 14/12/2020 08:33

So what happens if a volunteer takes the dose, goes home and comes down with covid a few days later? How do they determine whether that is a reaction to the vaccine or a coincidental infection contracted outside the clinic?

And for that matter, what happens if a volunteer contracts covid just before taking the vaccine? Might they not have to put the volunteers in "quarantine" for a few days before receiving the vaccine to avoid this possibility?

[pierre oreilly] 14/12/2020 08:27

There's no reason at all that a phase 1, (or 2 or 3) should be done in a very expensive secure facility.This is better news than many think imv. No one is getting booted out of pre booked beds for the study imv. It's in addition to the fully booked challenge study work - at least that's how I read it.The recent Pfizer and other vaccine did all the phases with no secure facility bed stays afaiia. Our secure facilities are there for when we infect volunteers with viruss which don't want spreading to the outside world (,I.e for challenge studies). Not in the bizz, just my opinion.

[judijudi] 14/12/2020 08:24

They don’t all have to have the vaccine taken together at the same time
They could do 2 x 24’s with each of the 24 stopping at the facility

[1gw] 14/12/2020 08:16

I don't think you can really be absolutely sure from the announcement. By stressing that it's going to be done at the "24-bedroom quarantine clinic" the implication (to me) is that the beds are going to be used for this study. On the other hand 48 volunteers and 24 beds means all the volunteers can't be in beds for the whole study period. I would expect this sort of study to be turn up, get the dose, go home and report periodically for evaluation - but perhaps because the vaccine is based on the whole virus they need to keep volunteers in beds under observation for a number of days after they receive the dose - just to make sure they don't develop covid from the vaccine dose itself.

[john henry] 14/12/2020 08:11

Great news, however looking at the initial PA imho another tranche of shares have been dumped on the MMs. I'm wondering if Invesco has started selling these past week ???

[pierre oreilly] 14/12/2020 08:11

How long do you think the rns says they will stay in the qm clinic?

This is work additional to the work requiring the beds which are fully booked anyhow, at least that's how I understand it.

[judijudi] 14/12/2020 07:58

Yes they stop at our facility
It says as much in the rns

The study will evaluate s afety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO's state-of-the-art Quarantine Facility in Whitechapel, London

The Company has already begun enrolling volunteers for this study in its unique East London, 24-bedroom quarantine clinic through hVIVO's dedicated volunteer recruitment website: www.flucamp.com

The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.

[pierre oreilly] 14/12/2020 07:56

1gw, are you sure this phase 1 requires any time in beds? I don't think it does. I think this contract is in addition to the challenge studies which have all the qm beds booked for the next 18months iirc.

Could be wrong, but I expect they visit the clinic for a medical, then for exposure to the vaccine, then just answer phone surveys ( a la covid phase 1 2 and 3), with possibly a final medical at the end of the phase 1 in the spring. In all probability, I'd expect hvivo to get phase 2 for this vaccine if phase 1 is a success, and probably a challenge study if phase 2 goes well.

[adorling] 14/12/2020 07:55

World class leader in Human Challenge Studies including Covid-19 now fully approved by MHRA to proceed. This is significant news and fully endorses what our CEO has always said as well as the quality standards hVivo/Open Orphan have submitted to the MHRA.

Hopefully we shall now see a push back to the previous highs of 32p IMO.

[molatovkid] 14/12/2020 07:37

Excellent....should get some attention!

[bobsworth] 14/12/2020 07:33

Fantastic News!No stopping ORPH now on this game changing MHRA approval!This should wake the market up now and attract some serious world press coverage . Pays to be patient eh!

[steve73] 14/12/2020 07:32

Interesting to note that we have a working time-machine...

[1gw] 14/12/2020 07:31

This will be done in the QM clinic, starting in January. CF has already told us that QM is fully booked until the end of next year, so clearly there must be some conditionality around some of the bookings. i.e. if MHRA had not approved the study starting for some reason then the beds would not have been filled for this study and presumably some revenue would have been lost (compared to the alternative of it going ahead), even if there was a non-refundable reservation fee already paid.

This is part of the difficulty for analysts in valuing the revenue streams I think. When CF makes a statement about things being "done", what residual risks are there?

[owenski] 14/12/2020 07:18

This might be the green light that everyone was waiting for and takes the risk out of the - will they get CHIM's approval or not - dilemma.

There will now be more conviction in the touted future revenue stream coming from CHIM's.

So, not a financial RNS but a very important announcement IMO

[rivaldo] 14/12/2020 07:16

This is great PR for ORPH - and of course highly financially rewarding too during H1'21:

"MHRA approval for nasal COVID-19 vaccine clinical trial

First in human trials for vaccine candidate with the potential to confer long-term immunity"

[judijudi] 14/12/2020 07:12

Nice start to the week