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Replies to post #73537 on PharmaCyte Biotech Inc (PMCB)
Thank you for your email and for your interest in PharmaCyte Biotech. Austrianova is not preparing the Master Cell Bank (MCB) or the Working Cell Bank (WCB) because this is not something that it does. For a very long time, Austrianova and ViruSure have been working on the different types of genetically modified cells we have been considering for use in our clinical trial. It wasn’t until we met with the FDA in January 2017 that we knew which of several cells we were developing could be used as the one to encapsulate and use in the company’s clinical trial. Currently, Austrianova is conducting several types of complicated and time consuming tests on that cell line, in addition to the required characterization. As mentioned, the development of a MCB and a WCB is not something Austrianova is capable of handling at their facilities. There are only a few companies in the world with the facilities that can handle the large-scale production of a MCB and WCB. The company we’ve contracted with, Eurofins Lancaster Laboratories, is one of largest in the world and among the best in our judgment.
Yes, the cell banks have been ordered; however, because the time it takes cells to grow is always different, we can’t answer your additional question about the delivery of those banks with complete accuracy just yet. With regard to your question concerning delays in submitting the IND, there have not been any delays. Everything takes time and because of this, we have never given a date or timeline for the submission of the IND.
