Member Info for Sangijuelas1

I don't know about trial results derisking 4D.

It looks like they are giving up on the last gaspers and looking to get better results in earlier treatment lines.

If they did RCC trial in the refractory patients and got only stable disease for 6 months I don't think approval would be possible.

At least not without showing significant impact on the Overall Survival metric and maybe Quality of Life but that takes a lot longer to get the data.

Basically need to see tumour shrinkage. They were unlucky as 1 patient did have a response but it wasn't sustained long enough.

Phil you are hoping for positives from Oxford.

And yet all they have done so far is lend 4D $5m for business use.

If you were going to assign probability to that coming through what would you say. I would say maybe 20% probability.

Remember 4D have been in talks in the past according to DP- FDA for fast track 0518 approval and other potential partners for Blautix. Nothing has come of these talks so I have learnt to take what he says with a pinch of salt.

I have told you many times what I think the positives are. But circumstances have changed mainly trying to raise in a biotech bear market when several hundred others are also looking for funding at the same time

I still own stock because they may solve the funding issue and carry on playing the game.

I still think there is value in the MRX drug discovery platform, which may lead to buyout rather than any particular individual LBP like 0518.

But they are in a bind. Can't raise the cash they need at this SP without massive dilution and the market knows they are running low.

I am working on probabilities with imperfect information so it's all best guess.

I reread your entire posting history.

It took me 16 seconds.

Who are you?

Yeah but when combined with actual responses to bolster the case.

The ORR there was 18%. Pretty low so they are saying look at the stable disease.

4D ORR was 0% so stable disease all we have.

I don't think that will be enough for accelerated approval but hopefully will warrant further study.

Phil do you understand nuance?

I am holding because I think there are still positives in play and in the hope that they resolve the cash question.

I am challenging the claim that 0518 results are the best in the world ever, which you did not challenge earlier as you are happy for false info to go unchallenged.

You would be more credible if you also challenged those making over inflated claims about the potential for success here

Boonco that was a P3 trial in 175 patients

And there was an overall response rate of 18%

The claims are the views of the researchers themselves

Phil, I am not saying the results are not worthwhile. My hope had been to see some partial responses as could have been a base for accelerated approval.
I would also have liked more clarity on the results delays in NSCLC or bladder cancer.

I think Blautix has commercial potential but they have no money to run a P3 trial in 1000 patients or so. Any potential partner will know their cash situation so that diminishes the opportunity.

Yeah I think takeover target but also why would Merck buy now when they know 4D are getting low on cash?

As I said, we need funding. When that comes I would consider topping up.

I honestly think Bavencio trial is on hold because of the cash situation.

Do you agree that at the time of the Oxford loan they had anticipated a fundraise of $45m or so by now and that was probably derailed by the biotech bear market and the depressed SP?

Combined with cash concerns I saw a drop in the reward profile and a rise in the risk side.

Phil I am challenging the characterization of the results as brilliant.

Hopefully they were good enough to warrant further study but I don't think they will be a basis for any accelerated approval.

A response for a start Phil. A tumour reduction of 30% or more in a couple of patients.

Stable disease for a few months is a bit borderline for doctors to send patients off for intravenous Keytruda.

Phil can you point me the way of a post where I suggested the results were brilliant.

I said they were decent but inconclusive , which is not an overwhelming endorsement.

Phil, Kaleido were still running a P2 and initiated a partnership with Janssen at the start of the year.

Look at their website, which is still up.
https://kaleido.com/

Unlike their SP which is now 8c down from over $4 before Xmas

They realised that they were going to run out of cash so decided to call it a day.

Yeah Phil, I know you prefer magical thinking about the 0518 results rather than an honest appraisal of them.

To push the line that they are brilliant in the hope of fooling people is a bit sad.

They were looking to enrol 130 patients.

In Feb last year they said they had 24. On this years update still only 47.

Someone has come on here claiming that the 0518 results are the bestest results ever.

With no explanation as to why. We just have to believe and buy because Number Go Up.

The results were OK. It sounds like they are going to look to get better results at earlier lines of treatment rather than relying on stellar outcomes for the last gaspers. So accelerated approval less likely.

Sometimes people have to adjust their views when new info comes to light. For me that was the Oxford loan info and the 0518 results that would ideally have been better.

And can you tell me what I have lied about?

Can you explain what makes the 0518 results so good then, beyond the fluffing of them, which the company is obliged to do where possible?

How many responses were there as per Recist criteria?

That would have got me a clear fail on any higher education submission for marking.

Somebody said. I presume that you are talking about Porky.

The primary endpoint for Part B was very vague.

Signs of Preliminary Evidence of Anti Tumour Activity.

The Secondary Endpoint would have been better. This was an actual measured anti tumour effect, which was not achieved.

So the evidence is fairly inconclusive although hopefully worth doing further investigation.

What do you mean?

That's 20 minutes of my life I won't get back from someone posting crap that they don't understand.