Hmmm, interesting timing and the specific nature of your last contract, Hedley. As you've mentioned several times, supply chain logistics takes years to set up, not weeks. When did you get that 'ah ha' feeling after plandemic and solution announced?
Yes, as for the last contract, it hit me later that they must have known what was coming. The gene therapies then were all for CAR T autologous therapies (patient specific for rare blood cancers). Never in a million years did I think they would change the name to VACCINES, but the the other products weren't selling at $475,000 per treatment. Nice little earner, eh Markker?!
The unlimited hang out link I posted earlier is well detailed on points you've covered re dire straites of pharma and desperation for a block buster, or two. By recatergorising as "vaccines", less testing required, indemnity (that's why they got put on kids' schedule to get this, apparently), why worry about safety as long as Wall Street and shareholders kept happy?
All good Markker, except the testing requirement is the same for all drugs, including "vaccines"; also, I don't think indemnity exists outside the US, and they can be proven defective/fraudulent, or misbranded in US terminiology...
Thanks for the comment Markker - I knew instantly when they announced the timelines. The rolling review approval process they used only ever considered the time to set up clinical trials, which can happen in months. They ignored the need to build a supply chain first to run safety studies in animal models. That typically takes 3 years (US GAO official figures). Then for the three phases of trials in humans, it takes c. 7 years. There is (was!) a regulatory limit to how much you can scale up @ 2.5X the existing batch size. Then US GAO says typically it takes FDA/EMA 12 - 18 months to review and evauate all the data, before making a decision. It seems no one thought to ask if safety studies had be carried out on what the supply chain produced, rather than a single batch made at lab scale.
Moving back to doing things like development in-house makes obvious sense as traceability and accountability are under visible control. At the other extreme, was there ever any sense, or GxP sufficient traceability and accountability in the notion of a virtual company?
Never Charles, as we have discussed many times. My next book for Wiley will cover that in some depth, along with a way to return to vertical integration - thanks for your continuing support :)
Hmmm, interesting timing and the specific nature of your last contract, Hedley. As you've mentioned several times, supply chain logistics takes years to set up, not weeks. When did you get that 'ah ha' feeling after plandemic and solution announced?
Yes, as for the last contract, it hit me later that they must have known what was coming. The gene therapies then were all for CAR T autologous therapies (patient specific for rare blood cancers). Never in a million years did I think they would change the name to VACCINES, but the the other products weren't selling at $475,000 per treatment. Nice little earner, eh Markker?!
The unlimited hang out link I posted earlier is well detailed on points you've covered re dire straites of pharma and desperation for a block buster, or two. By recatergorising as "vaccines", less testing required, indemnity (that's why they got put on kids' schedule to get this, apparently), why worry about safety as long as Wall Street and shareholders kept happy?
All good Markker, except the testing requirement is the same for all drugs, including "vaccines"; also, I don't think indemnity exists outside the US, and they can be proven defective/fraudulent, or misbranded in US terminiology...
Thanks for the comment Markker - I knew instantly when they announced the timelines. The rolling review approval process they used only ever considered the time to set up clinical trials, which can happen in months. They ignored the need to build a supply chain first to run safety studies in animal models. That typically takes 3 years (US GAO official figures). Then for the three phases of trials in humans, it takes c. 7 years. There is (was!) a regulatory limit to how much you can scale up @ 2.5X the existing batch size. Then US GAO says typically it takes FDA/EMA 12 - 18 months to review and evauate all the data, before making a decision. It seems no one thought to ask if safety studies had be carried out on what the supply chain produced, rather than a single batch made at lab scale.
Moving back to doing things like development in-house makes obvious sense as traceability and accountability are under visible control. At the other extreme, was there ever any sense, or GxP sufficient traceability and accountability in the notion of a virtual company?
Never Charles, as we have discussed many times. My next book for Wiley will cover that in some depth, along with a way to return to vertical integration - thanks for your continuing support :)