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flipper44

08/27/18 5:02 PM

#187444 RE: Lykiri #187442

Thanks Lykiri. Another indispensable find. I hope someone stickies your post. Here is that entire paragraph.

I believe innovations that address capacity and manufacturing at commercial scale and volumes will have the biggest impact. While I certainly believe automation is Important, it's just not the biggest driver at the moment in my opinion. We partially addressed the urgent need for capacity ["help"] by building out more suites that are both US and EU compliant and expanded our focus on delivering commercial scale production. We’re also working on being able to offer a more complete service, including innovations developed internally and externally via partnerships that will enable modular automation and other improvements that will increase product viability and volumes. We have several big things in the works that will address multiple aspects of product development and manufacturing that I wish I could discuss at the moment but can’t. All I can say is please stay tuned. https://www.phacilitate.co.uk/article/preparing-commercialisation-right-cdmo



[ ] and underlining were added by me.

Doc logic

08/27/18 5:43 PM

#187446 RE: Lykiri #187442

Lykiri,

You are right on it. Good job! A little hint to NWBO investors about product development and automation.."Have they identified areas in the process where a simple change, a small modular automation can affect product viability?" Now in terms of a clinical trial situation, change the word "viability" to "characteristics" that need to be disclosed to regulators and you have an interesting scenario. Now couple this with "We have several big things in the works that will address multiple aspects of product DEVELOPMENT (emphasis mine and not in quote) and manufacturing that I wish I could discuss at the moment but can't. All I can say is please stay tuned."

Your analysis of the last 100 or so patient's was interesting Lykiri especially in light of these quotes. Have you found anyone to second your opinion? Best wishes.

sentiment_stocks

08/27/18 6:42 PM

#187455 RE: Lykiri #187442

Very interesting Lykiri! Thanks for alerting us. :)

On a related note, when considering the costs to run the P3 trial, Cognate CEO Ganjei had this to say,

We know, owing to our extensive phase III autologous experience, where upwards of 90 clinical sites was required, that it is a round-the-clock operation and we know what to expect in these situations when time translates to a patient outcome.



How much does anyone think this "round-the-clock operation" might cost?

Virgilio

08/27/18 7:45 PM

#187469 RE: Lykiri #187442

Stay tuned!

JTORENCE

08/27/18 7:51 PM

#187473 RE: Lykiri #187442

Lykiri so what makes you think that he was referring to NWBO? They do work for many companies.

CaptainObvious

08/27/18 8:04 PM

#187475 RE: Lykiri #187442

Lol. Stay tuned to the same Bat-sht crazy channel.
Will do

john1045

08/28/18 6:48 AM

#187506 RE: Lykiri #187442

Great find Lykiri and I found CEO's quote interesting and positive as he obviously is speaking about NWBO and DCVax-L.

There are some CDMOs that have handled all of those aspects up and downstream but not necessarily at the scale that’s needed for commercialization or are too focused on making the client use the CDMO's particular IP, which doesn't always work for the client, or they haven't had the breadth of experience in autologous therapies. We know, owing to our extensive phase III autologous experience, where upwards of 90 clinical sites was required, that it is a round-the-clock operation and we know what to expect in these situations when time translates to a patient outcome.