Hey Matty,
Dr Campbell is a very intelligent man and that is one of the reasons for my investment in this stock, but - having said that - you'd be a fool in thinking that he - at this moment - knows exactly what it is that's causing the problem with the production of PAT-DX1.
If he knows what's going on then the latest quarterly would have read much differently.
For argument sake let's revisit it:
(my emphasis)
"...to date has
not identified any systemic issues that could have caused
the issue that
resulted in the termination of the previous production run. Accordingly the findings of the reviews by
both the CDMO and independent, external evaluator
suggest that the unexpected manufacturing
issue was
most likely a one-off event."
In other words:
- it's not a repeat of the issue that halted the previous production run
- Because it is not clear what the problem is we suggest that, perhaps, it's a one off event...
Let's keep in mind that it is a 'one off event' until it happens again and if it does, then - by definition - it ceases to be a 'one off event' and what's left to sum up the extract above is a
"No Clue".
Looking at the bigger picture, the clock is ticking.
After advertising the fact that biologics move to commercialisation faster than small molecule - ironically because they are easier to produce than small molecules - the mayor patent (the patent that covers 3E10 variants, including Patrys’ lead candidate PAT-DX1, for treatment for
several challenging cancers) was filed in
2015, granted in 2017 and
expires in2031.
Consider the picture below and it's hard to maintain certain arguments about this being somehow just another typical biotech hitting a "pot-hole" along the way.
I would like to express more optimism but I'm long in the tooth and a bit of a realist, I have divested a sizeable chunk as I need to protect my capital and it looks to me as the spectre of a CR at a discount is taking shape because - as the most intelligent Dr Campbell knows - potential is not going to fund the activities past the next 2 quarters.
FIGURE 1Drug discovery and development timeline
NOTE: FDA = Food and Drug Administration; IND = investigational new drug; Mfg. = manufacturing; NDA = New Drug Application.
SOURCES: Sigal presentation, December 12, 2016;AACR, 2011.
From:Proceedings of a Workshop
The Drug Development Paradigm in Oncology: Proceedings of a Workshop.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; National Cancer Policy Forum.
Washington (DC):National Academies Press (US); 2017 Jul 24.
(20min delay)