As this drug is meeting an unmet need it may qualify for fast tracking. And this is what CHM is aiming for.
If this happens, only one more trial will be required after this phase 1 trial that is running now to gain drug approval. Google FDA CarT drug approvals and you will see this is common if the drug works. The FDA has given fast track approval to other CarT drugs that have a 79% adverse event rate. They do this as the patients have no other choice.
GBM is agreesive. Life expectency is not long. Few patients make it to 5yrs. So if CHM can show some efficacy during this phase 1 trial, there is a good chance of fast tracking. So drug approval sub three years from now is possible. If it works.
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