Replies to post #261466 on Avid Bioservices Inc (CDMO)

[vinmantoo]

that was exactly the kind of thing we were all told to believe about the PII 2nd ln NSCLC PII data that suffered the dose switching by our CRO, CSM in Fargo.

The FDA was NEVER going to accept the PII data because of the DOSE SWITCHING.

Wow, are you really comparing getting a go ahead for a phase III trial with an unprecedented alteration of FDA process to get Bavi approved? You aren't expecting FDA to make the unprecedented alteration of FDA process when the only controlled Bavi phase III trial was stopped at the first look in for futility, are you? What can't you understand? There isn't a single robust phase III data set, controlled or uncontrolled, and there won't be unless PPHM starts an entirely new trial. There is nothing for the FDA to review. Just wow!!

[eb0783]

You hit that one CP they were all saying this BS back then and again now. Or as Yogi Berra would say, "deja vus all over again."

vinmantoo, that was exactly the kind of thing we were all told to believe about the PII 2nd ln NSCLC PII data that suffered the dose switching by our CRO, CSM in Fargo.

The FDA was NEVER going to accept the PII data because of the DOSE SWITCHING.

Now you say:
Quote:
The FDA will NEVER throw out or ignore the control arm so that Bavi or any other drug will get approved.


Why do I feel to have the benefit of the doubt here?

Because the FDA did IGNORE the Dose Switching, did give a PIII SUNRISE clinical trial approval and IGNORED IT SO MUCH that they did even give a Fast Track designation on top of it ALSO based on that SAME always called 'Butch Data'.

[vinmantoo]

vinmantoo, that was exactly the kind of thing we were all told to believe about the PII 2nd ln NSCLC PII data that suffered the dose switching by our CRO, CSM in Fargo.

The FDA was NEVER going to accept the PII data because of the DOSE SWITCHING.

CP, not sure why you think EVERYONE (not me by the way) said the FDA would never accept the dose switching data to allow the phase III trial to proceed. I have been clear that the dose switching and the high number of dropouts makes it difficult if not impossible to reasonably predict how Bavi + Doc would do in the phase III, and that impacts trial design.

See my exchange with a poster named dia76a about 3 years ago on the Biotech Values board.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=89564924

More to the point, why in the world would you equate some people making comments on a board being wrong, to the FDA dramatically altering its policies?

As a final point, someone raised doubts about my being down on PPHM before, or not making predictions in the past. These are some I made in July of 2013, when I had a series of exchanges with a PPHM long named dia76a.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90277946

{{1) Do you think the FDA will grant Bavi a breakthrough designation?

ANSWER: I don't know. That is a FDA decision. }}

MY RESPONSE: Too bad you didn't have the courage to make a prediction. There is NOTHING is any data generated to date with Bavi that will justify BTD designation


{{2) Is so, when will this BTD occur?

ANSWER: I don't know. That is a FDA decision.}}

MY RESPONSE: Obviously it is an FDA decision. The FDA will not grant BTD designation because none of the Bavi data generated to date merits it.


{{3) When will a deal be made with PPHM for Bavi and what company will make that deal

ANSWER: Likely within 6 months. I don't know which company...there is the sort of silence that you would expect when there are confidentiality agreements.}}

MY RESPONSE: There will not be a deal in 6 months.


{{4) If a partnership deal is made, what kind of up front cash payment will be given to PPHM?
a) less than $1 million
b) under $10 million
c) $11-$50 million
d) greater than $50 million

ANSWER: I expect upfront cash payments of $50 million or more. }}

MY RESPONSE: If a deal is made, PPHM will get less than $10 million. I wouldn't be surprised if it were less $1 million or even a no cash deal.}}