Replies to post #135232 on Avid Bioservices Inc (CDMO)

[bigdumbandugly]

I believe PPHM is open to going it alone for Phase III and that is a mistake since it is going to take a long time while potential studies for other indications are sitting around. I really hope that I am wrong


sadly i don't think you are, ku.
and once underway there is many a slip twixt cup and lip.
i do not think pphm can do it on their own - and what's more, i can no longer afford to have them scuffle along on their own on my dime.

all imo.

p.s. my 'dime' that was once about 2 dollars.

[Protector]

ku, after the trial setup PPHM is NOT allowed to be involved AT ALL (FDA regulation to be enforced by CRO).

The jobs you describe are up-front one time jobs to be performed and PPHM already has the people who performed these tasks for the other trials, including NSCLC PII. SO they don't need to hire them. And by the way a very big part of the preparation is already done, Q4/2013 is in less then 2 months so there is not much time left.

And as set out before there is certainly no KNOWLEDGE TRANSFER involved at a level that one would need dedicated people to perform it. Knowledge is the MAIN asset of PPHM. If you transfer it then you do that under a kind of agreement (partnership, buy-out, etc).

By the way in such Clinical Trail Sponsor-CRO protocols as they are called everything is in writing! There is nothing that you need to know that is NOT UPFRONT written down so that in case of conflict the documents represent what was agreed upon. I am not sure but it could even be that the FDA has to declare them 'conform' with their regulation (eg: the FDA states that if you perform what is agree it is within FDA regulation and within the approved PIII design). So afterwards you NEVER have discussion about what you INTENDED to do, at the most about the way you did or did not execute those intentions as meant!

[jakedogman1]

given past history and the santa claus option handouts at the asm, I doubt anything happens that would increase share price before the asm. if anything I see mgmt using the atm to suppress share price (and give cheap shares to partner in the wings) while coming up with confusing pr's in the meantime. business as usual and screw the retail shareholder.