Just with regards to the “no adverse events have been reported so far”. They wont normally release this information on any public database not until (I’ve tried to find these databases because I know they report it or keep a database of it):
- The FDA halts the study due to a safety issues, or
- They release any results regarding interim analysis and final analysis via presentations or publications.
In a clinical trial, there will always be adverse events, and it can be as simple as getting a rash or requiring surgery because a subject tripped and broke a bone. The important question on AEs is regarding whether the AE is caused by the drug, leads to death and hospitalisation, and is unexpected.
Chimeric will create a safety database and will report the serious and unexpected ones to the FDA.
Unfortunately, by the time we have any public knowledge regarding these serious and unexpected adverse events, the study would’ve been halted by the FDA and the ethics committee, and our stock price will be plummeting without any warning.
To close on a good note though, the fact that Chimeric has moved forward in dose seems to indicate that there have been no serious and unexpected adverse events occurring in subjects that the FDA deems significant to discontinue the trial, which is a good sign. I’m bullish on their CLTX Car-T product because there’s really nothing like it in the market and in development.
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Just with regards to the “no adverse events have been reported...
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