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The fast track question was asked of Dr Tap and I think to be fair his reply was a bit of a wait and see. Apparently the FDA fast-track is very much a work in progress. However if he wasn’t excited by the potential of preCISION why would he be presenting at White City. Though I admit his presentation went right over my head.
On the Avacta front Sloan Kettering and Fred Hutch are lined up for presumably 1b and there could quote be 1 or 2 others.
I believe Dr Tap was answering a question from Paul Hill towards the end of the panel Q&A. His answer to a successful outcome to the trial was standard of care quote ‘Overnight’ Hopefully retained in the recording but it was 100% said
Personally I agree but I know Avacta believed, as do their brokers, that the material market overview was given in the 17/1 rns. If we chose not to believe it that was up to us.
The AVA3996 pre-clinical data as I understand it matched or even exceeded the AVA6000 data. This is another major step in confirming the value of the extensive preCISION pipeline. Exciting times. I believe what I’ve said in my posts this morning is fair and accurate information to be judged when the video comes out. I believe Myles is going to publish his own more detailed information which will also stand up to scrutiny against the recordings
To Efficacy
I am very much a layman so I hope I am getting the below 100% correct I think I am.
As Alastair says this has never been an efficacy study the regulatory body would hang them out to dry if they tried to say it was…..BUT
The combination of PK data & the consistent data from the biopsies confirm the Prodox is being cleaved in the TME leaving an optimum or above optimum level of active (just normal) Doxorubicin in the tumour. The table Myles mentions is the comparison of Dox in the biopsies to plasma and as he says varied across the 6 from I think one at nine to a couple well over a hundred. Far exceeding the mouse model. So to say we have Efficacy we have to have an efficacy controlled study aimed at the tumours with high level of FAP that Dox is already successful. What we have now is the knowledge that the preCISION platform does what it says on the tin releasing active Dox in the tumour. Historical data confirms Dox efficacy against numerous tumour types. So if it looks like a duck, walks like a duck and quacks like a duck we just need a duck study to prove it’s a duck!
The 1a trial has matched or even exceeded pre clinical data. The safety and tolerability has been monitored from day 1 and the data is clearly tabled. Though it’s incorrect to say there were no side effects the side effects were in the main minor and the data has confirmed the comments there are greatly reduced or no side effects across the body graphic we now see on the website. Prof Twelves made a couple of very interesting comments I hope they were recorded ‘dealing with Prodoxorubicin and doxorubicin is like dealing with chalk and cheese (in a positive way) & ‘we are nowhere near finding a MTD dose yet’
Avacta believe that they told us everything we need to know in the 17/1 rns where they clearly stated it works and yesterday they started to publish the data to back that up. I agree in that I think the live streaming should have been available to all but brokers demands are what they are and it was also open to the chosen few. We are making comments from the data set yesterday and discussions with the scientists involved. The published video will prove their accuracy
Recording of Science Day will be out tomorrow late afternoon. Apparently probably after market closes for no other reason that that’s how long putting the edit together will take. A lot of interesting data to support previous rns. Prof Chris Twelves was there he was very engaged with speakers. I’ll post some more tomorrow and just before anyone questions Yes Myles was there.
I got the LFD so wrong so I hesitate to point this out but hasn’t this changed? I read it now from the website as a statement of fact no mights or coulds ………..preCISION Technology tumour micro environment activated cancer therapies THAT TRANSFORM PATIENT OUTCOMES.
I can only repeat the Buffetism…….The stock market is a device for transferring money from the impatient to the patient. Let’s see what tomorrow brings I believe there will also be information on the strategy going forward. The mood music from Avacta does seem to be good but it is just a step on our journey let’s hope it’s a significant step. Not long now for limited data release. Good luck to all shareholders
I hope for serious discussion
So science day for…In-depth insights into the preCISION and Affimer platforms , wider company strategy and pipeline.
Dr William Tap chief sarcoma medical officer Memorial Sloan Kettering ….’Current & future treatment strategies for soft tissue sarcoma