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TRUE!!! ...and that was funny RC
He’s undoubtedly itching to PR a new CRO...has to be!
The year is not over till it’s over! :) :) :)
Ultra-7....U7
Maybe a good name for at least one of the many strains that will be started there? :) :) :)
Well, then bring on that CRO PR!!!!! :) :) :)
Definitely!!!
Hoping Eurofins production of our cells got off to a good start and showing promise of success. Just glad we were able to get back to the original cell culture medium.
We probably won't hear another word on the CypCaps and testing from Austrianova until both are completed.
I think KW will PR each event upon their completion with a final PR announcing the IND submission....kaboom!!! :) :) :)
Just think of the board members as being "lab" related, whereas PC is "field" related.
What keeps me confident that we’ll have a successful trial is Von Hoff agreeing to maintain his consulting.
New CRO PR coming soon enough. :) :) :)
Efood, PC managed all the aspects of Otonomy’s clinical CRO.
PC provides clinical trial management and consulting. They are not a CRO.
They probably could be (with minimal services), but they’re not.
If the CRO search goes according to the way KW explained, Sher’s team will engage in the process of selecting a larger CRO, and PC will manage that selection.
Hope that helps. :) :) :)
Go PharmaCyte!!!
Going out on a limb here...
With CRO’s there are different organizational and operational differences.
KW stated:
“We are extremely grateful to those prominent oncologists who have agreed to join our Oncology Advisory Board to assist ”us” in finalizing our clinical trial protocol and in sharing their views on how best to achieve our goal of making our therapy available to those patients who desperately need an effective treatment for LAPC. We received invaluable input from these experts in pancreatic cancer that should allow PharmaCyte to enter the clinic with the best possibility for success.”
Who could “us” be?
If you’re having such a meeting, you’re probably working to align your new CRO’s protocols, processes, and procedures with the FDA requirements.
Go PharmaCyte!!! :) :) :)
I hope you’re right! As a matter of fact, it makes more sense to meet with the board after a new CRO has been picked rather than before.
Perhaps a new CRO has been picked. After all, both KW and the board were already aware of the TD2 dilemma....no need to meet just to beat a dead horse.
Geeze, can you imagine the stress KW has had to endure doing his own dd to re-establish trust in a new CRO all the while safeguarding CiaB’s proprietary information.
If indeed that is the case, then I would think Von Hoff and Practical Clinical guided KW through the selection process to some degree...it would surely save time.
lol I would like to think that at the point of their discussion with the new CRO, where KW asked for a reference, it went like this:
KW: Well, do you have a reference?
new CRO: ahhhh...Dr. Daniel Von Hoff
I mean why not?, he’s been involved in so many trials.
I like the experience they have, Maybe their just too small.
Then again, maybe not. :) :) :)
I agree Kano...sounds good
I believe in one way or another von Hoff is tied into that “suggestion”.
As far as any conflict with TD2...it’s certainly possible.
I mean the timing of that negotiated contract and TD2’s “said” notification of their infrastructure problem certainly could be viewed as a questionable coincidence at the very least.
What if the new contract was struck because of some certain foreseeable changes and/or developments. Changes that TD2 may not of been happy with. Then perhaps a conflict(s) did arise.
BUT, I myself, tend to think what KW said....is so.
Reason being, if there was a conflict, I just don’t believe von Hoff would still be participating. If KW says TD2 doesn’t have an adequate infrastructure, then I believe it. And soon, a new CRO will be chosen.
And who knows?...it could very well be a Canadian CRO. :) :) :)
I can say one thing is certain, if there was indeed “any” conflict...we’ll never know.
Yes, I agree. However, I'm not as concerned about it being announced by eom as I'm concerned about the time the CRO has to prepare.
At this rate, it is highly possible that the caps, banks and testing, could all be done well before CRO is complete and ready for trial.
I thought it would of been the other way around, whereas the CRO would have been prepared, waiting for the caps and banks.
Oh well...???...guess I'll just continue to be patient as it all continues to roll out. :) :) :)
I’d say that there may have been CRO candidates discussed.
Still looking for that new CRO PR before end of year.
There is only so much leg work KW can do for CRO. Running out time.
Need to choose and contract new CRO asap.
I agree RC
I've been here watching this board for over two years now and have yet to see one single chart forecast a significant movement upward.
Which then makes you think that it may very well could have been Practical Clinical to come up with the suggestion to bypass the WCB.
PC??? ...think about who they are, and where those three have been.
I think PC may now be contributing significantly to KW’s thinking and planning.
It’s crazy to think how fluid all of this still is, but that’s ok with me.
There’s way too many strong points throughout this whole project to think that there won’t be success one way or the other in the end.
Then the FDA is obviously ok with it.
It does make sense with regards to saving time. And besides, the WCB is derived from the MCB with no added materials....so why not?
I guess KW mention both at the time as it is standard planning, or protocol.
Hey Rayla, doesn’t the CiaB therapy have to be proven first
I’m thinking that if the WCB isn’t needed, then why is a much bigger CRO necessary? Can the trial (a must) really be accomplished with only a MCB?
I like the fact that the Practical Clinical staff being a former VP, and two Director’s, all from Abraxis/Celgene, would have had prior dealings with many CRO’s in their past at one level or another.
With both Sher and PC now knowing the experience and capacity needed in a CRO, I believe the pick will be a successful one.
But of course, with that comes the inevitable cost factor. A cost that we all know KW, as always, will manage to pay for.
Regardless of who it is or how much they cost, I still think we will see a new CRO PR before the end of the year. :) :) :)
The trial preparations will be in an enormous undertaking. I don’t see it going unannounced.
I believe the CRO PR is likely to happen before that.
Thank goodness
I felt the same way with the last PR.
When KW said that he had authorized Eurofins to begin production I knew that did not mean that they had actually started the production.
Great to hear. Still have two huge mountains to climb and “get over”.
Just realize we’re nowhere near out of the woods yet....just sayin.
Go PharmaCyte!!!
But RC, KW has already mentioned that he is working with interested entities to get funding... and there’s really nothing more to educate.
I’m thinking, if anything (w/Diabetes and Ascites aside) we only have the MCB/WCB production and the CiaB encapsulation results left to learn. And even then, KW will more than likely announce those outcomes himself.
What I think KW is waiting to use Morell for is the big splash, and that will obviously be the IND submission announcement.
Meanwhile imo, ahead of that major announcement, both KW’s cell bank PR and his encapsulation PR will drive the pps upward before that.......wait for it......BIG KABOOM!!! :) :) :)
Go PharmaCyte!!!
Agree
Kaboom catalyst”s” coming Q1 ...if not sooner. :) :) :)
So, it’s commencement (???) then roughly 12 weeks, plus roughly 6 weeks.
Counting a few minor setbacks, I think conservatively we can say IND Q2.
Authorization of the cell bank production is one thing, but commencement is another.
Without knowing exactly when production starts it’s hard to say when the IND submission will occur.
It is however, highly probable that the encapsulated cells will be completed and tested before the cell banks.
I’m expecting the next PR to announce the new CRO.
Then the next PR to announce the completion of CiaB’s production and positive test results.
And of course a final PR announcing the completion of the cell banks production with positive test results.
Go PharmaCyte!!! :) :) :)
MCB and WCB is basically one process, same production.
Produce, divide, and then separate and designate.
That’s my understanding.
Absolutely!!! ...I’ve always thought the FDA's rigorous safety and efficacy standards with testing would be the Mt. Kilimanjaro
Now with Eurofins only having to complete the production our waiting shouldn’t be so stressful. It’s their expertise. :) :) :)
Definitely encouraging news Pete!!!