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The USFDA has reviewed and commented on the results of the phase 1 clinical trial of NBM-BMX and suggested changes on the draft clinical protocol of the phase 2 program
- In 2018, in a letter approving the initiation of phase 1 clinical trials, the USFDA requested NatureWise schedule an end of phase 1 (EOP1) meeting with the FDA when NatureWise completed the phase 1 clinical program.
- In September 2021, NatureWise completed a phase 1 clinical trial in the USA, submitted the trial results to the USFDA along with a draft of the phase 2 study protocol for glioblastoma multiforme, and requested an EOP1 meeting.
- In December 2021, in the response letter for the EOP1 meeting, the USFDA commented on the trial results and suggested changes for the phase 2 clinical study protocol. NatureWise will follow the USFDA’s recommendations to revise the clinical protocol and ensure that it meets the USFDA’s requirements.
- In the same response letter for the EOP1 meeting, the USFDA also laid out future studies that will be required to support the NDA filing and final product registration in the USA.
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