PharmaCyte Biotech Inc (PMCB)

[1234jklm]

january 2020 before ind can be submitted

..the entire process is not yet as consistently reproducible and robust as required by the FDA as we cannot ensure that the end-products of these manufacturing runs will convert the cancer prodrug ifosfamide into its cancer-killing form as well or consistently as they should.

We have a problem.

They are not consistently triggering chemo the way they should.

We have been in intense discussions with Eurofins, Austrianova and our cgmp guy and several consulting cell biologists to try to sort this out. The extent of specialists we have had to consult shows it’s a fairly unusual and uncertain situation and we really don’t know what to do.

We think we can probably fix it so cells are always the same and always trigger the chemo. But we don’t know.

We need to do more work to get there.

We are doing it.

We think we can do two more production runs, one after the other to solve this but obviously we need to do lengthy tests after each run. Eurofins took 3.5 months to do these and so we should take another 7-8 months to do both runs and test them.

Add a few weeks to finalize documents for the ind Submission and we should have a chance at a submission in 8 months time.

January 2020

Meanwhile the trial preparations are moving forward.

Is this what the release actually said? Isn’t this it without the spin?

Look we are all adults and we can cope with the truth.

Kw. Please call a quarterly update and tell us what is happening.

Spinning information just makes people nervous and destroys their trust.
Or is there something I got wrong?