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Friday, May 07, 2021 9:35:24 PM
Post by TimGDixon » Fri May 07, 2021 2:27 pm
Phase 2a's, 2b's and 3's oh my
I see a lot of talk about phases of trials and i think its best if i help correct some of the perception.
I think everyone is sort of talking about a phase 2a of JadiCells and the regulatory pathway forward from 2a - 2a can become2b and there is absolutely nothing wrong with that - thousands of companies do 2b's for a variety of reasons - since when having any APPROVED IND would be a downturn? Thats completely backwards - many companies choose to do 2b's because it affords additional data before you get to the really hard stuff in phase 3's. Some companies already have the additional data that would be mined from a 2b and instead go to 3. But lets never shoot ourselves down by thinking that a 2b isn't extremely valuable. They are when necessary.
We have never mentioned a 2b anywhere to anyone and what we said that has been overlooked in this PR (https://therapeuticsolutionsint.com/the ... g-disease/) in the sub headline was "Clinical Stage Immunotherapy Company Aims to Initiate Phase III Clinical Trial to Register Life-Saving Universal Donor Lung Protecting Therapy".
If i said we are aiming for phase 3 why would you extrapolate 2b from that heading? Obviously we said it because we know we have all the data a 2b could provide and so it is in confidence we said Clinical Stage Immunotherapy Company Aims to Initiate Phase III Clinical Trial to Register Life-Saving Universal Donor Lung Protecting Therapy.
Tim
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