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ND I appreciate the point you make, see my post to Ophidian above. Wait for the phase 1a data and we will see a shift towards talk about phase 2 being sufficient. Even then phase 3 will be mentioned in passing. If you remember sng001 last year after initial data the assumption was that phase 3 wouldn't be required. RM made valid points that they wouldn't require p3 and I personally would have agreed with RM vs FDA. However a p3 was required but with substantial help from the FDA who reduced the number of patients required by 33% in an already small cohort.
If we don't see this as a digital 0 and 1 issue and who is right and wrong. From my perspective, there is a very very strong chance that p2 will become pivotal and p3 will not be required. From yours I guess it would be that there is a small chance it could.
GL
I agree Ophidian that it doesn't / won't require a p3 and I speak from having witnessed many companies in a similar boat. The likelihood is very very small and all depends on the FDAs view. However, not many publicly listed companies and CEOs will shout this before phase 1a data. In the meantime it is best for them to talk about phase 3 at least in passing.
I would add that the moment phase 1a pK data comes through end of year/ early next, we'll see the company emphasis change more and more. If you want further details on my thoughts DM me on twitter and I'll try and expand on this when I have time.
GL
Ophidian....ships in the night.
AVA 6K Phase 3 not required.
In his Paul Hill/Vox interview of either 25 Feb or 17 March AS emphasised that Doxorubicin is a mature product not requiring Phase 3 trials.
Don't shoot the messenger.
@marik - AVA6000 doesn't need big expensive P3 trials as there is 40 years built up data base and knowledge in Doxorubicin. It is effectively (a very clever) line extension - a new delivery system if you wish and will be pivotal at phase 2.
Ophidian
Phase 3 can be very big or in some cases relatively small. There is another covid therapeutics company on AIM. It is currently on phase 3 with data by end of year/ Q2 2022. They have less than 700 people in the trial and the FDA reduced it to less than 700 in an effort to accelerate the progress and approval. How many people in phase 3 "if" required?
Both the "if" and future n values will depend on data from phase 1 and 2. Should be fascinating over the next 2 months.
The majors are and will be knocking on the door, once we have a preliminary phase one trial update.
So far we have had only indication from the management during investor presentations post result that he is very happy with the ongoing trials.Have not suggested that anything has gone wrong so far and off course hospitals are lining up to participate .
218 rather than 118
LLnP, thanks for bringing that attention. Although not the same thing and not really competition, you still make a good point. Imfinzi (durvalumab) which some of you may or may not know about was approved years ago. However the recent study came out with data not today but last week (not BTC but for HCC) in a *combination study* and also last month. Todays data was a for a rarer indication. From the HCC data, the improvement in survival has increased the share price by £3.8B in four days. Note also that it's a combination study and secondly note that this has already had news last month as well.
I would say AVA6000 trial will excel beyond this due to the number of drugs in the pipeline, but for a second let's go along with LLnP's excellent post. An equivalent rise would take Avacta beyond £15 per share (that's not including any further increase from other streams of revenue). The upside is genuinely very big and once the early Pk data is released, it will open up the pipeline for multiple Avacta pro-drugs and the re-rate should be very positive. Combined with revenue from the diagnostics and other partnerships, it derisks the investment to some extent, making the risk reward quite enticing.
Not quite the same thing I know, but an example of the ‘space’ pre|CISION is playing in …
https://www.europeanpharmaceuticalreview.com/news/164503/imfinzi-improves-overall-survival-in-biliary-tract-cancer-btc-patients/
Look at the scale of the trial – 145 centres in 17 countries. Note the following ...
“Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy and is the global standard of care in …”.
Now remember we have pre|CISION PD-1 inhibitor in the pipeline.
What if pre|CISION turned out to better in turns of overall patient outcomes than this (or other ‘big pharma’ products)? Or even just looked like it might. Are ‘they’ the competition, or are we?
Just saying.
GLA