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Am i reading this right, under who else is applying . Patients from California used in p1 ? sorry if already known and i missed it.
https://www.withpower.com/trial/phase-1-sarcoma-6-2021-6f477#eligibilityCriteria
Quite possible we are after one of these.
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation
Good example of process. And reassuring to have the team Vlad has built around him.
https://www.hallorancg.com/2021/04/13/cell-and-gene-therapy-initial-ind-submission-considerations/
https://www.thefdagroup.com/blog/a-basic-guide-to-iq-oq-pq-in-fda-regulated-industries
https://uraholdingsplc.co.uk/investors/publications/, under the Company Documents tab.
https://www.pointbiopharma.com/our-products/pipeline/canseek
Reading MyHealthChecked PLC (AIM: MHC) RNs looks like Launch is a real bargain.
Considering we got large discount on covid sales.
This better-than-expected performance was driven by the demand for COVID Lateral Flow tests ("LFTs") COVID testing remains the largest revenue stream for MyHealthChecked, and demand is expected to continue during 2023.
Copied this from David Chan MD:
In cancer clinical trials, if a study drug proves to be effective, patients who are benefiting are permitted to continue that drug even after the trial is completed.
I had a patient who was having a great response on a trial that turned out to be negative. The study drug was no better than standard treatment.
Yet, for that individual patient, the study drug effectively controlled her cancer and the pharmaceutical company allowed her to continue that medication for over 4 years even after the research was stopped and the experiment drug was shelved. Eventually it stopped working and I switched her to standard treatment.
Good read. A.I, T-cells
https://pharmaphorum.com/views-and-analysis/jpm2023-breakthroughs-await-but-so-do-roadblocks/