Member Info for Scinv_temp

Another advertisement lmao

I hear it's the illuminati doing their shenanigans again. Maybe a letter to George Soros would resolve this at the next Bilderberg meeting?

Quick reminder that you heard it here first well over a month ago

Scinv_temp

Posted in: HVO

Posts: 944

Price: 17.10

No Opinion

EMA/CHMP official guidance on clinical evaluation of vaccines 29 Jan 2023 07:10
16 January 2023
EMEA/CHMP/VWP/164653/05 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) (responsible for approving medicines in EU, they co signed this month).

Human challenge trials are accepted for:

correlate of protection studies (this is a big chunk of vaccine trials) see section 4.2

Efficacy see section 4.7 and effectiveness, see section 6
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-vaccines-revision-1_en.pdf

Hopefully, co remains sharply focused on quickly expanding when necessary instead of trick or treating shareholders

Lmao that's an advertisement

Who knows? Maybe then polb can also publish something. Because for a company that is all about science it is a bit weird they have ZERO scientific publications, they didn't even publish the protocol of the phase 2 and in the results they reference statistics that are not shown in the data they presented.

Part 2

3. They said they expect to get market exclusivity in US, Europe etc. Lmao. Let's say it works and eventually they do get approval in US. What will probably happen if they relied on their patent for market exclusivity (they don't, instead they said they rely on FDA giving them NCE) is the companies that have their own p38i they prepare to go to market as well (most likely they will start preparing after polb has a succesful phase 2, not after approval) and they are not even going to ask polb because their arguments are really weak.

This is not an original idea, many studies have suggested use of p38i in viral infections going back over 15 years. Now let's say they complete development (so a clearly succesful phase 2 and phase3) and get to the finish line with no other company doing the same after the successful phase 2 AND the FDA decides to give them some protection. They get 5 years of exclusivity. I would be extremely surprised if they manage this. But let's say they do manage, forget the billions some people here dream of, it isn't the same as a 20 year exclusivity window a PROPER patent would allow, here they rely on the regulator to give them some limited protection. Most of you didn't notice probably, but they base their strategy not on the patent (obviously) but on getting NCE from FDA that would maybe allow them the 5 year exclusivity window). But, really, given the data they presented, are they really going to get there, imho, it is unlikely and in any case there is a loooooong road ahead.

OK that I have some time let's go through the Q&A part

1. As previously stated, in the skin lesions part the drug seems to have a very transient effect so a few hours later inflammation takes its normal course as if the drug was never there, as the professor explained. He explained this is due to the PK, well yeah it has a short half life before it gets metabolised away so obviously a few hours later there is no availability any longer. Now this is very common, sometimes even desirable. BUT, if you are in conversations with pharma you can't dismiss the fact that 3h later you are back to zero for whatever reason, you get grilled for that kind of answer.

Why? Because this particular part of the trial tests directly what the drug does to actual inflammation as a patient would experience, not simply the biomarkers that are predictive of inflammation. Now here is the more interesting part, they already had the PK data in humans before they even started the lps challenge study since there was a phase 1 prior to that, this is why the dosing was twice a day for this study as they clarified also in the Q&A, then why is there only a single dose shown on this graph? They could have done a separete single dose to see what happens and that's fine but clearly the majority (if not all) of the subjects got 2 doses per day. So where is the data? Could it be that the drug does not do much when there is sustained inflammation?

2. About the profylactic use vs treating directly the most severe cases they were very clear they would go after the latter first. Well then why didn't they use a model that represents that? They pre treated 3 days prior to challenge with the endotoxin which is the opposite of what they are trying to achieve here. This is going to be pointed out as well in a discussion.

Continues in next comment

She thinks £100k is alot. Lmao

Continuing with the slides and later I'll comment on the Q&A

Localised iflamation first slide, same as before, no error bars in all sample, no statistics, transient increase in TNF instead of sustained.
On the 2nd localised infl slide (laser speckle imaging), same issues as before plus, it seems there is just a slight delay on inflamation at 3h anf from 9h onwards all treatment arms look similar to placebo. Not only that, but the images on the left not omly are not very representative of the graphs, but the time point is not indicated either. Is it the 3h time point in the treatment sample and the 24h timepoint in the placebo? Who knows? This is the kind of mistake one expects a phD student not to make after their first month in the lab.

As an umbrella comment, by far what bothers me most is the absence of statistics esp since some quite impressive p values were mentiined in the rns. To then present the actual data and not indicate where exactly those pvalues correspond and the method used to calculate them.

Good morning pumpkin, did you sleep well? Btw that never happened and lies will only get you that far.

Forgot to add something important so far.
The lps only induced tnf for about 2 hours in placebo which may not be consistent with sustained hyperinflamation that is the case with viral infections or car t-cell therapies

Watching it now and I'm at 25%
Notes so far
No statistics so far (I'm at the body temperature/heart rate slide) just descriptive data which is highly unusual and unscientific.

Some data (placebo for example) has error bars but the treatment arms mostly don't therefore not possible to assess the result properly. This is dodgy as f.

This was pretreatment with drug 3 days prior, this is consistent with developing it as a preventative of complications rather than treating an already existing one.

This would have been fine until I heard the good (?) Professor say that it is good science, which is nonsense. Whe n yu decide to dose depends on how you want to develop it.

In al the graphs the placebo arm starts with a clearly higher baseline than the treatment arms, which is strange esp because it is so consistent.

In the heart rate graph, all the treatment arms had a heartbeat base line of about 50bpm (wtf all of them were 19yo athletes?) While the placebo arm had a baseline of about 60 bpm.

Will continue later

Little Tommy never understood science. Otherwise they wouldn't be clapping this mess all the way to the bottom.

A few hours later the blarney turned into the world is not enough. And you give advice to people. Lmao

Plus the 100M+ moniman wants to sell it. Lmao

The key question here is, who is going to pay the 100M+ required to get this to approval(phase 2 and phase 3 + all other legal/regulatory/manufacturing) when barrier is so low?

Clueless fools moving across to polb. There, I fixed it.

If they release a moster pharma deal rns I will say that I am a clueless m0r0n. There, it's a deal.

... to some obscure biotech/fund for peanuts obviously

Yes. It has been stated many times, you are absolutely right.
So if they come back and say "we have to do another trial ourselves" or if they outlicence to some obscure biotech/fund instead, what are you going to say then?