Replies to post #166673 on Avid Bioservices Inc (CDMO)

[cheynew]

I think it is as they expected probably. Shan said we would get a hockey stick and probably meant they would bring on new sites in stages and then enrollment would skyrocket.

[swg_tdr]

only the big USA ones matter right now, say 10 with 20 enrolees over 3 months, and it will be slow as patients come off the first treatment and decide with the Oncologist what to gamble on

regards,
N

[golfho]

“how do you think of enrollment form sunrise trail, only 12 sites until now ? not as much as i thought or not ?”

I’ve been thinking about that as well.

Here’s my 2 cents… FWIW

I’ve been tracking the trial sites and posted about it in my post #163655

“I’m not sure how the 12th trial site was identified but I am maintaining a spreadsheet comparing the previous trial sites with the new trial sites. The 12th site added was “Peregrine Pharmaceuticals Investigational Site - Savannah, Georgia, United States, 31404”
So currently there are two sites in Georgia as there were in the PII trial but they are not the same sites. The N.H. site was added as part of the 9 additional sites added in January. And, thank you nh for identifying the site in N.H. If anyone can identify a trial site in their state please post that info and I will replace “Peregrine Pharmaceuticals Investigational Site”. I will periodically post the spreadsheet (As soon as I find out how…!!!)

Spreadsheet Summary:
To date 2 sites are the same
5 are in new States and
5 are in the same States but in different cities”

NOTE:
NO ex-US sites. Why?

In the previous PII trial there were:
24 US sites
2 Georgia sites
15 India sites
7 Russia
5 Ukraine
So…24 US sites and 29 sites in eastern Europe & India.

I would like to bring to everyone’s attention what Steve King & Shan have stated TWICE.

“We also remain on track with our regulatory and ethics approval timeline for rolling out European and Asia-Pacific sites over the next few months.”
In slide 16 of the Roth Presentation:
“Single Phase global registration trial >100 sites (US, EU and Asia Pacific)”

To me that is one giant tell…!!!
1 – E.U. That in NOT Russia, Georgia or the Ukraine.
2 – Asia Pacific is NOT India.

Hmmmm…

What could that signal?

1 - There will be a E.U. partner
2 – There will be a Asia Pacific partner

NOTE: Slide 19 lists many powerhouse E.U. BP’s & we have our Asia Pacific candidate in Takeda

When…? ”Over the next few months”

With 2 BP’s we get the long awaited hockey stick.

Regards
golfho

[funworker1]

sorry, but i have to say it again. we have a special website for the sunrise trial, there should be about 100 clinical sites after xxx time, now after 4 month we have only 12 sites, only state sites, nothing international. i do not know if we already heard about first treating. i think so, but not officially. all this disapoints me, because a sunrise is something special in time, the sun does not need much time to rise, as well its beautiful to see the sun rising in the morning. ok i know, sounds.....


regards
fw1