Tuesday, June 27, 2017 3:31:11 AM
Thankyou for posting the Dr Lohr video which explains that when ciab was first tested the ability to reliably reproduce cells was not able to be done with GMP compliance.
The reason the delivery method was abandoned for so many years was not because no one wanted it but because cell production had to catch up.
Austrianova have now solved the cGMP of cell production required for this delivery method which has given it a new life.
This has been a major reason why previous hopes for ind for ciab were delayed. The cGMP has only recently been established and the facility tested and approved.
Once again this shows the careful patient, methodical process the company has followed to bring ciab to FDA testing.
The production of the master cell bank and working banks is now underway by austrianova and should be ready by 3rd qtr which allows the ciab delivery method to be submitted for ind protocol trials for the first time.
Very exciting
All those claims about Mr Waggoner not meeting deadlines are uninformed.
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