The below extract was in GMV's 21 October 2019 response to the ASX query (which I thought clarified that a new Chief Principal Investigator had been appointed)?
The reasons for the delay in obtaining the NMPA approval are as follows:
(i) the Chief Principal Investigator (PI) for the leading hospital sadly and unexpectedly passed away in June 2019, resulting in delays to the clinical trial. Having regard to this, additional time was required for the NMPA committee to nominate and approve a new PI to the Company, to allow the new PI to review and adopt on-going clinical trials (processes, paperwork, logistics, protocols) and to re-orientate the supporting clinical staff to the trial to the new PI's specific expectations, requirements and protocols. The process recommenced in August 2019;
(ii) new clinical trial protocols had to be submitted to the NMPA, as well as to two additional hospitals, being: a. the Guangzhou Women and Children’s Medical Center - which occurred on 25 September 2019; and b. the Zhujiang Hospital of Southern Medical University - which occurred on 16 October 2019;
(iii) in consideration of the summer period, it was substantially more challenging than expected to identify and recruit qualified patients presenting obligatory symptoms for the relative clinical trial, particularly patients registering outlier range requirements for temperature data; and
(iv) the ethical committee at the Shenzhen hospital (being the nominated clinical site for volunteer SPO2 trial) had indicated to the Company that they would have convened to consider and approve the protocols to the “controlled SPO2 reduction” clinical trial at a committee meeting in July 2019, however subsequently cancelled this meeting and postponed it until the end of September 2019.
Final approval to approve the protocols to the "controlled SPO2 reduction" clinical trial has now been received and was provided to the Company on 15th October 2019.
GMV Price at posting:
8.4¢ Sentiment: Buy Disclosure: Held
