Open Orphan Share Discussion Threads

[wassapper] 27/11/2020 10:23

Trader and m5 - very interesting. Thanks. Looks like we are on in Jan, dispelling some lingering doubts by some perhaps.

[1gw] 27/11/2020 10:20

pogue - I'm not sure that's correct - about upping the dose until it does harm. They do pre-clinical (i.e. animal) studies for that, where they do deliberately give multiples of the dose they might give in human trials to find out when they start getting adverse events.

By the time they start on human trials, phase 1, they have a good idea from the animal models what an effective dose is and how high they can reasonably take the dose before they might start to see an unacceptable level of, or unacceptably serious, adverse events.

My understanding of Phase 1 trials is that at that point they are setting out to confirm in human trials that the range of doses they think is safe from the pre-clinical trials actually is safe in humans. Regulators are unlikely to give approval to human trials, I would have thought, if the intention is to use "unsafe" doses.

[pogue] 27/11/2020 10:02

Pierre
giving someone something until it causes harm is what they do in Phase 1 trials that is the intention find the safe limit to do that you have to cross it which is by definition doing harm.
Pointless debate we are not getting anywhere useful I started by challenging Nick on his assumptions but makes no difference to ORPH.

[pierre oreilly] 27/11/2020 10:00

James, 25ish needs to rise about 25% to get to recent highs.

[pierre oreilly] 27/11/2020 09:56

P, the oath isn't about outcomes, it's about intentions. Lots of things drs do harm and even kill people, but the intention it to help them.

[malcolmmm] 27/11/2020 09:55

Most probably more dangerous crossing the road statically than having a mild dose jab

[pogue] 27/11/2020 09:52

discojames
I was trying to point out that challenge studies are no different to phase 1 tests for drugs side effects. I am not arguing against challenge studies just debating with Nick who says challenge studies are the only tests that contradict the do no harm ethos of the medical profession. I am all for challenge studies if volunteers are willing and are advised of the risks then they are worthy of praise, and payment, for trying to help the common good just like soldiers who volunteer to fight and possibly die for their country.

Pierre
you made me think for a second there, Challenge studies are allowed in the UK as you say but imagine they weren't then ORPH could easily decamp to another country that did. Very worst case I am sure the Chinese would welcome us with open arms though I imagine Belgium would be handier for CF.

Edit
Troutisout
I am not taking it too literally, side effects of drugs can go from zero to fatal quite rapidly I image, one minute you are fine next your are not how severe is the unknown but a trigger for something to shutdown may just be a slight increase. The reason of phase 1 trails is to test what dosage causes side effects not if they cause side effects, subtle difference.

[666james] 27/11/2020 09:50

Just got quoted 25.11p to sell a little over 100,000

[discojames] 27/11/2020 09:45

Pogue, the difference is it is all done under incredibly close medical scrutiny. If you take a pill at home you may not know about the side effects until they're quite severe, in a Human challenge study with constant monitoring and blood tests you will know about any change very early. Just like how virtually no cancer is lethal if caught extremely early and very dangerous if caught late. Imagine if your body was scanned every single day for cancerous cells it would be unlikely for you to ever die of cancer

[pierre oreilly] 27/11/2020 09:39

Yeah, there are arguments on both sides, and no right or wrong answer. Hence why some countries allow them and others don't. In that respect it's like the death penalty or abortions or chlorinated chicken.But the salient fact is challenge studies are allowed, and today encouraged, in England at least. Hvivo seems to have a monopoly on them, and the signs are, as well as being fully booked now, hvivo will be fully booked for the foreseeable future with challenge studies. As well as being great for orph's finances (that's an understatement!), It's also great for mankind. Not often you can say that with share investment.

[troutisout] 27/11/2020 09:36

Pogue,
I think you are taking too literally the piece you posted the other day, phase 1 is about safety and finding out what doses can be safely tolerated in patients, they don't try to go to the point where everyone is seriously affected and the say that is it. They try doses and if anyone has side effects they will then rein it in and lower the dosage. These are also drugs and vaccines not live virus.

[trader_3] 27/11/2020 09:32

UK Gov Secretary of State – Human Challenge Project

Contingent liabilities relating to the contract signed between the Government and Imperial College London for the human challenge project.

“The first step of the project is the virus characterisation study. This will begin in January 2021”



Another important step and confirmatory statement from UK Gov ref Covid CHIM’s in the New Year.

Everything seems to be slotting into place nicely.

IMHO

[pogue] 27/11/2020 09:24

Pierre
phase one ups doses to patients until they find out the side effects that makes them ill what is the difference from that to making someone ill with a virus both have the same effect of risk to life.
I had a tablet a couple of years ago I had to stop very quickly taking and see the doctor as I started having certain side effects that were leading to kidney failure, all listed on the PIL sheet. On the PIL was one whole side of a page on the side effects ranging from moderate to see your doctor now if you experience any of the below. To find that out someone had to have the drug in increasing doses and risk kidney failure among other nasty things.

[m5] 27/11/2020 09:20

We getting moved ready to taxi? :-)

[troutisout] 27/11/2020 09:06

Nick
I don’t it is every ten years, had one last year.

[little minx] 27/11/2020 08:59

Surely the share price must be about to tick up

[pierre oreilly] 27/11/2020 08:17

P, phase 1 2 and 3 test the vaccine, intending to cure people, so drs can do it. A challenge study purposely infects with a virus, hence against what drs promise to do, under some interpretations.Some countries think it's wrong to purposely infect, others like the UK have a long successful history of doing exactly that for the greater good.There's no direct link between phase 12 and 3 and challenge studies at the moment, and no link to whether any vaccines are already being given to people. Due to the cost of phase 3, I'd expect a challenge study to be normally done after phase 2 in the normal course of events in the future to see whether an expensive phase 3 is worthwhile.

[pogue] 27/11/2020 08:04

Nick
Both injecting vaccines to push dosage to make the patient sick phase 1 and injecting viruses to make the patient contract the virus phase 3 are to deliberately make the patient sick I don’t see the difference. Do no harm is the motto but both set out to do harm in the name of science and progress.

[marvelman] 27/11/2020 07:55

Nick...a warm welcome from me and so pleased to read your very informative post. You are clearly a knowledge and experienced contributor who will bring another dimension to our excellent BB. Regards.

[john henry] 27/11/2020 01:40

Spread Bets uncrossing at mid.

[nickthe saint] 26/11/2020 21:51

trout,

dont have the Pneumovax every year please. Make sure the GP knows when you have had it if you switch Doctors etc - should be on the records of course. :-)

Pogue,

The difference here is that challenge studies inject the actual virus, expose the patient to disease.

Vaccine development does not - totally different. Vaccines are given to patients through the various Phases that are there to prevent the disease they are targetting. It can sometimes be a very mild version of that disease, but not always. Flu vaccine for example is not a "live" vaccine and therefore cannot give a person that strain of flu.

There are many nuances to vaccine development depending on what is being targetted. Penicillin being developed totally by chance.

To be clear I dont know loads about the development of vaccines, but I have worked in a multi-discipline Pandemic Flu planning unit.

I think there are a lot of positives about the Open Orphan Story and I certainly expect it to do well as a business, and well for shareholders.

regs

NTS

[troutisout] 26/11/2020 21:35

Nick,
I have the Pneumovax, Meningovax and Flu jab (although I sometimes forget to get that one, might have to get one for this year). Funnily enough not panic rushing for any Covid vax though.

[molatovkid] 26/11/2020 21:33

I think it is one side, bought in and waiting (me) and the other side taking profits from recent highs. As those sellers dry up and more buyers move in....then we move upwards.

I also suspect we have a big buyer. Price being dropped, sparks lots of sells and yet we are not collapsing.

[pogue] 26/11/2020 21:27

owenski
if you think about it the chart is showing what is happening in reality, people are waiting for news hence the flag is just playing out how people see the news flow going forward. One side is positive good news is coming the other thinks its not coming or will not be so good. Seems both sides are now almost in balance having bought and sold to each other and we await the sign that proves one side right and then a sharp movement as the others who got it wrong buy or sell to correct their error.
AIMHO, I am definitely not a chartist just trying to fit the facts.