Member Info for BuenaVista

Not in this weather

So you bought in and have now arrived here to ramp your investment. It's ALL about the money isn't it. Do you even know what you've bought into?

By 'lifted' I assume you meant lifted down?

Sleepy Joe just stirring.

Coffees being savoured, pretzels dunked. One hour till Joe turns on the intraweb thingy switch in his restroom if he can find it.

I'm willing to embark on a pub crawl round London this weekend if you're stumping up the expenses.

Why? Knowing for sure that organising a Science Day won't happen until the trial has finished isn't the same as knowing details about the trial.

Didn't we all take it as read that only a fool would announce a news release deadline and a big meeting date before the trial had completed, given how unpredictable the timelines on these Phase Ia trials are?

PSA level can be temporarily increased by infection or prostate massage (bike riding for example). Something to be aware of if going to give a blood sample.

No, they want to license the drugs made using the tech. That means not just the off-patent prodrugs already disclosed but also prodrugs of pharma companies' own on-patent best selling cancer drugs, if amenable to the tech (having a NH2 group capable of forming a peptide bond with 5140).

So, is anyone not at the bargaining stage yet?

Well an intraday would hopefully catch out traders and shorters.

Yes, it's looking like 7am on Monday for me as well. 31 days in January. Midpoint is noon on the 16th.

Friday is apparently not good for media coverage. Later today is a possibility but pushing it for weekend news coverage. Monday would start the week with a bang for everyone.

What's your thinking there gemstar? They knew their travel plans well in advance. The RNS could have been prepared beforehand.

In my book, Alan has until midday on Monday before the definition of 'early January' is definitely broken.

The letdown

I'm a LTH but I'll have to take a sleeping draught like last night. Too excited! There's a LOT hanging on the RNS and the reaction to it.

Luke blocked for disagreeing with the egotist RAH on Twitter. Now, there's a surprise. RAH! RAH! RAH!

Tbh, I think anyone who gives that fantasist any credence is.... not on the ball.

Yes, forgot to add in increases to maximum lifetime cummulative dose and number of cycles.

I wonder whether they would recommend different dosing regimens for different cancers...

There is none. All the information in the drug data records of the various services is already in the public domain. All that has changed is that AVA6000 has been added to all the other drugs in development or approved.

There is a very informative description on the Royal Marsden website of the clinical trials process for cancer in the UK, including how a Phase I trial like our own is set up and works.

https://www.royalmarsden.nhs.uk/about-royal-marsden/our-research/clinical-trials

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Drawing out just some of the content...

A Phase I study is designed to find out:

- what is the most effective dose of the drug and how much can be given safely. For example, the maximum acceptable dose and how often the drug can be given
- whether enough of the drug is circulating in the blood to affect cancer cells
- the possible side effects of the drug.

Phase II studies

Doctors use the information gathered in a Phase I study to help decide:

- the dose of treatment
- the frequency of treatment
- the particular cancers which may respond best to the treatment.

https://www.royalmarsden.nhs.uk/about-royal-marsden/our-research/clinical-trials/what-types-clinical-trial-are-there

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A possible reason for a delay, if indeed there is a delay, in providing the update in early January could be because desired changes to the protocol for Phase Ib need to be approved by the Research Ethics Committee and the meetings timetable and final decisions of that committee are outside Avacta's control.

I suggest this because desired changes to the protocol for Phase Ib would be decided upon after Phase Ia has completed and been analysed and there is agreement amongst the clinicians and Avacta about what should be changed to get the most out of the next stage. Phase Ia treated AVA6000 very much like it was doxorubicin itself - initial dose, dosing frequency and maximum lifetime cummulative dose - that is to say, following the precautionary principle. If Phase Ia has shown that AVA6000 is highly specific for tumours and barely, if at all, affects healthy tissue then the argument would be that these restrictions could be removed or at least relaxed. Thus the frequency of dosing and also the rate of dosing (concentration of AVA6000 and infusion time) could be changed. This would make Phase Ia more like a Phase II trial and speed the route to market.

https://www.royalmarsden.nhs.uk/about-royal-marsden/our-research/clinical-trials/how-are-clinical-trials-planned

The AVA6000 entry in one of the fee-based drug data services:

https://adisinsight.springer.com/drugs/800056369

The full record will contain more than this.