You in bold
Iam afraid I disagree to an extent.
Pleasedon't be. I find disagreement almost a pleasure when its with theargument.
Because of the way I access the HotCopper forum - I always use Tor Browser - my communication fluidity can get broken up. Sometimes I try to post and the posts just hang and so don't go through. I effectively never know if the forum post handling processes are going to allow my posts through until I hit the post button.
Some other posters like to get posts censored. "Why TF... " got removed for profanity. Why the fridge would they do that? Don't answer that's rhetorical.
TheFDA has been very busy with positive clearances in other aspects ofstem-cell therapies, particularly autologousand has approved a number of not entirely unrelated products
Fairpoint. And likely I've missed developments in autologous celltreatments. And I should read up more on FATE. I didn't say sobefore, but I do regard autologous (cells from the patient for use inthe same patient) to be different markets to off the shelf cells(allogenic cells) I think they'll have completely differentmanufacturing methods. And the blockbuster stuff like OA,HeartDisease, Asthma, I'm imagining and hoping will be able to betreated with off the shelf (allogenic cells) meaning the prices willbe much lower. But also meaning the manufacturing paradigm will befor volumes with significant economies of scale or they may nothappen if they can’t. I think they can happen – its likely to befeasible.
unlessI misunderstand you, to dismiss OA applications as 'not looking real'is a big oversight from an investment perspective.
Ishould have said "not looking real yet'. Idid actually write “until” but the sentence was clumsy.
Ihave two things in mind when I say yet 3Dmanufacturing paradigms will (?) [I'm going to go with the wordSHOULD] make 2D manufacturing obsolete in my opinion - unless itturns out that it cannot be done (which to me sort of defies logic as3D microcarriers essentially are 2D but in 3D volumes - though itmight be very hard to get exactly right - though a homologous cellsource like CYP has could be very useful in that regard) because 3Dwill be so much cheaper than 2D. Less labor costs – less human tohuman variability in the way human techs do the same job differentlycompared to automation.
Thesecond thing is that I think regarding regulator approval after phase 3 as thepoint of success is wrong. That isn't commercial success yet in my opinion. Its merely necessary towards commercial success its not sufficient. Nopoint having an approved product if the product can't make money atthe price you need to make it at. So this goes back to the 3D and 2Dthing but picks up a lot more to do with what makes for commercialscale (which is much bigger than clinical trial scale) scales ofmanufacturing.
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