#61737979
The (fast track) CTAP process has begun. We have received Pre IND (Investigative new drug) advice in response to our submission to the FDA, announced last Monday.
Biotron spent over 2 months compiling this submission with the assistance of U.S based advisors at the beginning of this year.
The following advice can be found on the FDA's website for CTAP, "we have found a complete Pre IND submission is key to expediating comprehensive Pre IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation."
In short, this is the most efficient strategy to progress a drug through CTAP.
The FDA have given clear guidance on a phase 2 human trial for C19.
Biotron are seeking funding for this trial, which should be happening quickly as we've had 6 months to plan and prepare for this.
From here, assuming the phase 2 human trial is successful, BIT 225 will continue through the CTAP process.
#61737979The (fast track) CTAP process has begun. We have...
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| Last trade - 15.15pm 03/05/2024 (20 minute delay) ? |
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| Last updated 15.15pm 03/05/2024 ? | |||||
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