Member Info for sadoldgit

Interesting.

'The second key difference between Phase Ia and Phase Ib clinical trials is the dosage of the drug administered. Phase Ia is the single ascending dose (SAD) study, wherein participants are given a single dose of the drug before close observation. If there are no notable adverse events, the expected pharmacokinetic activity is confirmed, and the dose can be escalated. This process is repeated until the maximum tolerated dose (MTD) is reached in human subjects. Once a third of all participants exhibit severe side effects with a particular dose, it is considered the MTD. In the event of adverse events occurring, the dose may also be decreased to reach the MTD.

In contrast, Phase Ib is the multiple ascending dose (MAD) study, which can offer more information with a faster route because these trials can simultaneously test multiple dosages all under one protocol. By comparing different doses across each treatment group, the researchers can easily compare the pharmacokinetics and pharmacodynamics at each of these doses.

More in depth in the link below.

https://worldwide.espacenet.com/publicationDetails/description?CC=EP&NR=2634185B1&KC=B1&FT=D&ND=1&date=20160113&DB=EPODOC&locale=en_EP

2.15 A compound of formula (2) or a salt thereof as defined in any one of Embodiments 1.38 to 1.105 for use in a method of treating a disease or condition in a subject in need thereof, wherein the disease is any one or more diseases or conditions selected from:

(a) skin inflammation due to radiation exposure;

(b) asthma;

(c) allergic inflammation;

(d) chronic inflammation;

(e) an inflammatory ophthalmic disease;

(f) dry eye syndrome (DES, also known as keratoconjunctivitis sicca or dysfunctional tear syndrome);

(g) uveitis (e.g. chronic progressive or relapsing forms of non-infectious uveitis);

(h) insulin- dependent diabetes (Type I);

(i) Hashimoto's thyroiditis;

(j) Graves' disease;

(k) Cushing's disease;

(l) Addison's disease (which affect the adrenal glands)

(m) chronic active hepatitis (which affects the liver);

(n) polycystic ovary syndrome (PCOS);

(o) coeliac disease;

(p) psoriasis;

(q) inflammatory bowel disease (IBD);

(r) ankylosing spondylitis;

(s) rheumatoid arthritis;

(t) systemic lupus erythematosus;

(u) myasthenia gravis;

(v) transplant rejection (allograft transplant rejection); and

(w) graft-versus-host disease (GVDH);which method comprises administering to the subject an effective TYK2 inhibiting amount of the compound of the formula (2)

Plenty to choose from

The added bonus Brighty1 is that an RNS announcement that we have been granted clinical phase 2 approval will raise the SP more than we are entering phase1b.

Regards

Although more applicable to 1802 it is worth having a quick read of link below regarding MTD.

https://www.pharmaceutical-technology.com/features/fda-drug-dosage-optimisation-guidelines-signal-clinical-trial-reform/?cf-view

With all respects to Edison l doubt they could differentiate between phase 1b and 2a

May well be a phase2 SDC1801 in a very short while.

Just an enlightened here.

What is the advantage of phase 2a over phase1b?

There is a degree of similarity in the to a certain extent both these trials achieve the same thing.

Effectively proof of concept that the inhibitor is or will likely provide a viable therapeutic treatment for Psoroasis.

Phase 1 trial establishes safety profile.

Phase 1b small number of patients up to several 10's

Can be no increase in therapeutic treatment, basically no exceeding 300mg per day. I doubt we would need anywhere near 30 mg per day anyhow for Psoriasis.

Phase 2a similar number of patients as to Phase 1b. Proof of concept.

Phase 2b, a larger number of patients normally around a couple if hundred. Increased dosaging v effectiveness here. The purpose of this Phase is to establish statistical data ( accuracy is related to the magnitude of count) that will indicate to a certain degree not only the tolerability, safety, but also efficacy.

When all proceeds fine then progression to phase 3 typically involving 1 to 2 thousand people.

At this stage, we are looking at long term effects and the evaluation of the compound continues dnd if this particular compound exceeds the safety and efficacy of the current standard of care, then apply for clinical approval.

Phase 2 by the very nature will have far more clout and add value as you have gone from phase 1 to phase 2.

Phase1b cab be put into progress znd whilst progressing plans can be made, via whatever means onlicence, partnership, or buyout can be decided on.

Regards

Apologies if a few mistakes as mobile phone misbehaving. It not allow me to read through.

Hbd,

I don't think takeover likely until development of 737 established.

It has potential and indeed once in combo has been found then it has a value.

Hard to treat cancers ie HGSOC being one.

Market is huge and still an area of unmet need.

Difficult to evaluate. Held back l believe by SO as a secondary measure to ensure no competition to the likes of the GSK pipeline.

Most know my views on this one.

SDC1801 safety data imperative and should we escape the dreaded black box warnings then that pits us at or very near the top of all else out there.

Phase2 is the way forward.

Phase 2 is way worth more than phase 1b.

Phase 1b will prove point of concept,however Phase 2 will establish most effective dosages.

Phase 1b we cannot progress beyond 300mg per day.

Plus there are other Indications of which some we will be best at. These need identifying.

All looks good as l see it.

Nearest competitor as l see it is Ropsacitinib a tyk2 jak2 inhibitor. Ok if the Tyk2 pairs with Jak 2 and hence control on iL 23 but jak2 is associated with EPO when paired with itself so concerns here will arise as basically one of the adverse side effects resulting in the Jaki black box warnings.

Will have a look, but not have lap top and hence stuck with poxy little mobile phone and not the enormous amount of saved research data on hand.

Next week l see SP in the region of 35 to 40p.

I may be wrong and what we have is day traders and nor investors as such. Most will sell once a profit of a few per cent is established.

Regards to all

Do you know Salfordred, l think to save money and make good for the share holder.

Equity finance, finance secured and trail can progress.

I think Tim and in the belief that as finance available and progress is made, subsequent drawdown is off set by an increase in SP

Ok, but in the event when shares placed on the market exceeding the demand the SP will fall.

This of course can be manipulated.

Same unfortunately with CTA application.

Strange that they seek independent world class specialists to investigate and trial our drug, but at the same time, finance and specialists knowledge equally important that have tried to resolve them selves. False economy.

We will grow from here.

Regards

I am ddep in thought as have circa 30k to put in. Do l buy now on a low?

Do l wait see if further money raise?

Do l go 50 50?

Will buy l think on this dip? If it goes past 32 p then sell 75% of newly acquired

15% drop then increase by 25% on top of the money taken from 75% sell

Need be careful as good news is due and round be better to know how Sareum chose to play the game.

Anyhow, Billy at the top with largest share holder value. In essence we are all in the same game irrespective of the shares we own.

If we all pull in the same direction then we will all be on to a winner.

Recently there has been a a few of the extremely disruptive poster. Started around Aug 6th. Just a few with an agenda that will stir up.

Not all bad for them as we have berks here quite happy to pay for a statue for them.

Regards to all the genuine

192,000 H&L ISA

55,000 H&L share account

116,000 IG share account

363,000 total.

Riverfort probably unloading the remainder of what shares they have then normality should resume. Steady rise until news released.

Regards

Good morning Lsesar.

Since we have been in discussions with interested parties, for what seems like an eternity, trial data would be shared with interested party.

Until.this data is known and confirmed very little can happen apart from very low ball offer.

My opinion for what it is worth is we will have absolutely no problems with daily doses up to 300mg.

Originally put as range from 12.5 mg to maximum of 1000 mg per person although therapeutic dosing giving mg per kg is the preferred means

Should we have a similar safety profile to Deucravacitinib with and increased efficacy in certain Indications, we will then not be tainted with black box warnings, it will leave us close to or at the top of auto immune inhibitor treatment.

In preclinical Sareum took SDC1801 to over 30 times treatment levels with no observed adverse effects.

Regards

It's heartening to see someone full of the joys of life.

Enjoy your day.

Funnyguy,

Operational disadvantage?

Australian clinical trials far more efficient and cost effective than UK. Added bonus of tax advantages.

This in reality is advantageous as can be shown from around the 6 week application time to acceptance. 6 months later and the MHRA cannot even state what additional information they require.

With regards to the above, this has no effect whatsoever whether a drug will pass or fail its trial objective.

I did not see SO returning 737 but had a degree of concern with no development for a period of 18 months.

We have a new private company in the US for licence as released in the RNS. I bet you did not see that coming.

As for Riverfort finance, l must admit l did not see that coming along with its death spiral. Long term proper, positive investors took care of that with WRAP offer.

As for

'So, i tell you what let's reconvene when all the results are known and we know the next step, until then it's all conjecture. So regardless of your ability to copy and paste form medical journals what have you got?'

So you admit to it all being conjecture yet cannot see your blinding error with regards to posting waiting for confirmation of failed test for Sareum.

On top of the copy and paste medical journals, l do understand them to a great extent. I have spent 1000's of hours researching.

I expect good results on what l know. Preclinical trial was carried out with attention to detail. Reports given by qualified scientists!

On the other hand we have you.

You already see failure as clearly you do not know even when the outcome is not known.

Regards

Regards

Funnyguy.

Your claimed 'tuppence worth' after reading is not worth anywhere near that.

What you have based your statement on has absolutely nothing to do with a kinase inhibitors safety or efficacy.

What l will say is that SDC1801 in preclinical was tested to over 30 times therapeutic dose with no adverse effects encountered.

Efficacy in vitro and in vivo were reported good

This information readily available by qualified scientists and you think you know better than them

Knowledge is power and clearly you have very little of either.

Regards

Funnyguy it is not opinion when you post

'We are not too far away from confirmation that Sareum have failed the tests and will not pursue.'

The above implies known reported failure,

You are nothing more than a little liar.

MHRA has nothing to do with testing you imbecile.

To go to Australia for testing at huge disadvantage operationally to Sar.

Where has a statement been made either expressed or implied that their is any operational disadvantage here?

As for the result?

Based on your ' confirmation that Sareum have failed the tests and will not pursue'

You don't know yet deliberately put up misleading information.

As for asking you on what factual material you base such a statement you fail to give a satisfactory answer.

I did not ask where those that opinionated flying through trials or close to a licensing deal gain their information. I asked YOU, where you get your evidence.

There is no evidence to suggest that. It has sweet FA to do with MHRA going to Australia or anything.

Now educate yourself sonny and don't post opinion as a statement unless you can clearly back it up.

You have failed abysmally to get anywhere near a fraction of a satisfactory reply.

Being here, as you claim for over 10 years it is readily apparent you know very little. You certainly have not been on this LSE chatboard as Funnyguy for 10 years

One more thing sonny I do not look at the leader board to chose who or what l invest in.

As for deserving to lose money? I don't think people making investments whether they go long or short deserve to lose money.

Clearly you have a big chip on your shoulder, you have already sold out here at a small loss as stated by yourself.

Clearly my investment strategy is different to yours.

Regards

Funnyguy,

Not sure what you mean by 'deserve any money invested'

I have been here since Aug 2012.

A long journey yes, even longer than l thought.

Companies have their ups and downs. These ups and downs do not change what the company has.

I believe in what they have created.

As you have no belief in what the company has created as indicated by your posting history, then what on heavens name prompted you to invest?

Regards

Funnyguy.

Opinion is one thing misleading or false information is something else.

This stated by you a few days back, can you confirm this is correct?

'We are not too far away from confirmation that Sareum have failed the tests and will not pursue.

On what factual data or statements have you based your above post, to give any credibility?

Correct me if l am wrong that if you have no such information to rely on, as l believe, then you have posted misleading information but also false information.

Regards

DrMicho how much is that likely to cost?

Are you looking at Phase 2a or Phase 2a and 2b.

What is the Sareum strategy?

Why has Sareum chosen to go for phase2a and not phase 1b as initially planned?

Lot of newcomers on here clueless.

Regards