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Re: oldmusky post# 75507

Wednesday, 09/27/2017 1:54:23 PM

Wednesday, September 27, 2017 1:54:23 PM

Post# of 144814
Yes, I think producing both a MCB and a WCB must double the time and expense. From the very impatient PMCB shareholder perspective, if the MCB can treat 50,000+ patients, why not just go with that? Well, the answers is after the original MCB is used up, PMCB would have to create a new MCB and then re-file with the FDA. Even if everything was exactly the same, the FDA would still consider it a new, untested biologic that has to go though a new round of testing.

So, from the longer term view, yes, you want a MCB that can produce WCB's that can potentially treat millions of patients. Do it once and do it right. From the viewpoint of any potential partners, because of the 12 year market exclusivity for biologics, you have to have the capability to treat millions and not thousands of patients over that time frame.

Finally, the testing of the MCB to produce a WCB is a double check of the freezing and un-freezing process and further validates the process.


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