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Great link to ISO 13485.
I was struggling on how to find information not having 30 years experience in drugs and stuff. But that linked saved the day.
Could have found any number of videos and beginners guides that provide an easier explanation just by typing in google or you tube, but that’s way too easy.
Some might suggest that the first link google gave was just cut and pasted in 30 seconds but finding a really dry, incomprehensible and phone hostile document takes a skill only a few have. Link to the standard, so obvious it’s genius. Making things look this easy takes years of experience.
My hero, does this man/woman/alien being have no limits to the skills and knowledge available at his fingertips. I bow in wonder.
Thanks, wait till I tell the kids someone thinks I’m Tom Cruise, awesome.
Of course the Colonel was found to be a liar and a delusional megalomaniac in the film, not sure if that’s what you were aiming at (is jest).
It’s ok to get it wrong.
ok - I'm going to leave the children to play for the weekend. Anyone who want to gain some real insight into the framework within which Avacta are operating might want to peruse ISO13485. This is just a tiny fraction of the regulatory burden they are wearing:
https://www.iso.org/obp/ui#iso:std:iso:13485:ed-3:v1:en
see you monday (perhaps)
Ophidian
Next week should hopefully bring in more tasty news, those last RNS were just treats to get us warmed up.
"I'll think about it tomorrow"
Scarlett O'hara
@Muck165 - Frankly my dear I don't give a damn
Rhett Ophidian
Haha Ophidian, Nathan Jessop - that was class.
Ophidian
As ever, you are the very definition of humility! A slight adjustment to another famous film quote, just for you;
“Mirror mirror on the wall, who is the greatest of them all?”
It is one thing to be clever and to share expertise, which you undoubtedly have, with grace and manners - BBN is a fantastic example. It is quite another to share it with pomposity and condescension.
Regrettably you have been filtered.
On reflection @Travel_Light forget my last post and try this instead:
With recognition and admiration of Colonel Nathan R Jessup: ( and tongue firmly in cheek)
You cant handle the truth! Son we live in a world that has diseases, and those have to be remedied by scientists with brains. Whose gonna do it you, you raucous drifter? I had a greater responsibility than you can possibly fathom. You whinge at delays, and you curse the scientists as slow. You have that luxury, you have the luxury of not knowing what I know, that drug product development while methodical, saves lives. And my existence while grotesque and incomprehensible, to you, saved lives. You don't want the truth because deep down in places you don’t talk about parties; you want me developing those medicines, you need me making those medicines! We use words like system, process, stability, We use these words as the backbone of a development lifecycle, you use them as a punch line. I have neither the time, or the inclination, to explain myself to a man, who rises and sleeps under the blanket of the very information and insights that I provide, and then questions the manner, in which I provide them. I'd rather you just say 'thank you' and go on your way. Otherwise I suggest you pick up a degree or two, 30 years experience and go do it yourself. Either way, I don't give a damn, what you think !
(meant in jest) Ophidian
@travel_light -
7. Additional batches made again at pilot scale to clinical standards for first time clinical evaluation. Supplied Wk1/Wk2 Aug Happening Now - Time to complete clinical Validation ~21 Days
8. In parallel with clinical programme; Scale up to production scale. Include Tech transfer and validation batches (again put on stability to generate data) Happening Now
Not really sure how much more clearly I could have said it. If Alastair had had my timeline in front of him and was reading off it it couldn't have been any more clear.
As a reminder - I gave you these steps, including which were in parallel back in early June. Now whilst the timing may have slipped slightly, other than including an extra step as 6b to explain the additional process step and hence the delay I'm not sure I could have got it any better.
Of course those drifting raucously through who think they are better and more clever will I'm sure seek to deride and criticise. I didn't post this up for my benefit - I know it. I posted it to try and illuminate for others.
So I guess @Travel_Light you can interpret what Avacta said anyway you like and either seek to reconcile or not with the outline I've shared for you - your choice.
Ophidian
Hi
From the release 6/8
Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies.
Isn’t this more item 4 on your time line. Unless you mean lab prototypes rather than pilot batches?
Few weeks delay which given the normal time line is still bloody good job by the teams involved. Nice of big Al to give them a public nod this week, hope he treated them to fish and chips also.
@Timster - listening to Alastair was quite pleasing actually as it seemed spot on with what I had suggested. On my Timeline we are executing 7 and 8 and as I had said - in parallel
Ophidian
@ophidian where are we on your timeline? Just listening to today's interview Sir Al says:
Pilot batch used for clinical validation
Validation batches
CE Mark after data obtained
Doesn't sound too far off