Bermuda on ADVFN.....1 Mar 2019 15:23
RE. your 20011, I think ONW is correct and well worth you having another listen to the recording of the AGM if you have it handy. The issue is in relation to the use of the Trigrid device in administration of SCIB1 - not the device per se. The exact words used were:-
'There's nothing wrong with the device, the device is fit for purpose. It's the data supporting the utility of the device for the delivery of SCIB1 that's the issue'
The FDA aren't going to just accept that the Ichor device is designed to deliver DNA vaccines therefore it all must be OK. They'll want to see procedures, processes, data etc. to show that the device delivers the expected dose of SCIB1 in the expected way, and that delivery is consistent and safe.
I knew that when submitting their IND, Scancell had to cross reference Ichor's master file which had already been accepted by a different division of the FDA. However, It hadn't clicked that the responses to the FDA's queries and the O/S requirements obviously also need to be sent to the different divisions. This means that Scancell will need to wait until Ichor have sent all O/S info. to the CDRH (I think) before they can send in their responses and request clearance of IND from the CBER.
Easy with hindsight but wish they'd just used the old device - we'd be discussing the results now.