PharmaCyte Biotech Inc (PMCB)

[purplehp]

Thank you, mwebb1514!

My perspective is one of bereavement. This is the only stock I own - so I want it to work.

That said, I have extensively researched what has been done. Many bits of information I actually got from the posters critical of the company - thank you for that! My interpretation, however, differs.

I think we all know PMCB is not a real biotech: it neither has the staff, money nor experience to be on par with a real biotech. Having expectations as of a real biotech is meaningless. Their progress is slow and their planning horrible but they have been making constant progress.

I would not comment on the management salaries because I have no idea what work they have done to overcome all the obstacles.

I consider their reporting strategy wise. I have never met a customer or a stakeholder who would want to hear of problems without also hearing that a solution has been identified and measures have already been taken. Seeing how the market reacts, what would have happened last year had they reported month after month about the setbacks? In the end, they managed to get back on track and I, personally, am OK with knowing just that.

This company is a gamble - no one can guarantee that, even if IND is submitted, approved and a trial starts, it will be successful. If you invested more than what you could bear to lose without regrets, than it probably was not a smart move.

Why I believe it is not a scam and has potential:

- it looks like it is the life's work of Lohr, Günzburg and Salmons. They never gave up on it and kept pushing (and are still doing preclinical trials for other applications)

- Austrianova actually got permission to do a trial in Europe back in 2004, so EMEA considered the treatment worthy
https://derstandard.at/1787145/Mittel-gegen-Bauchspeichelddruesenkrebs-im-Test
Unfortunately, they did not have the proper manufacturing facilities, so, despite a huge investment, they went bankrupt in 2008. There is an article describing the difficulties of a GMP production:
http://sgaustria.com/wp-content/uploads/2010/11/GMP-Production-of-an-encapsulated-cell-therapy-product.pdf
Austrianova built their lab in Singapore for the encapsulation but they still didn't have a facility for the cell banks. They can only since 2016 offer this service for preclinical (not what is needed now) https://www.eprbiotechnews.com/2016/01/26/austrianova-expands-its-business-area/

- the planned trial in Australia - please reread this PR - Abraxane has become the gold standard and was no more a suitable candidate for a comparator arm
http://pharmacyte.com/pharmacyte-biotech-issues-update-on-preparations-for-its-pancreatic-cancer-clinical-trial/
And, if I read this correctly, it was TD2 who suggested the change:
http://www.marketwired.com/press-release/pharmacyte-biotechs-ceo-explains-how-new-clinical-trial-design-changed-gmp-certification-otcqb-pmcb-2112486.htm

- the production of the MCB. PMCB has said enough times that this is the biggest issue. They didn't know that their cell line was not homogeneous? Not the only ones:
https://www.promegaconnections.com/the-cell-line-identity-crisis-old-problems-new-concerns/
Other failures..they don't matter anymore since, finally, Eurofins proved to be a reliable partner. Austrianova has already tested successfully the research cell bank and Eurofins should complete their tests on the master cell bank soon. Here is a comprehensive article about the process and how long it takes:
http://www.biopharminternational.com/mastering-cell-bank-production

- the trial should still be vs 5-fluorouracil (FU) and leucovorin (LV), which is the standard follow-up treatment
http://adisinsight.springer.com/trials/700243265


So, slow but steady progress. They have the facilities, the product and I am confident they will figure out the documentation as well, even if it takes more time than planned, again.


Other treatments trials underway don't scare me. The more choices in terms of effectiveness, costs and side effects, the more hope for patients.


Peace out.