Replies to post #73170 on Avid Bioservices Inc (CDMO)

[jonnyrocket]

I'd like some definitive answers too. It's a bit of a letdown to not know where we stand right now with Cotara since for the past year mgmt has been talking about this meeting with the FDA in the 4th quarter (originally 1H) to finalize a ph3 trial. I have no idea if this reply by the FDA that they'll supply written feedback rather than an actual meeting is a positive or a negative, and I don't like uncertainty, especially since mgmt has portrayed it for the last year that we'd have some answers by now. I know govt agencies and the FDA are unpredictable, though it's still a letdown to me.

I wish I knew how many other meeting requests by other pharmas have received this type of "we'll send you notes" response to a meeting request and package - and the percentage of those that were proved positive. I guess either PPHM's package was so thorough that they don't need a face to face and the FDA's written notes are all we need for a green light to move forward. Or, and what I'm leaning towards because 9 yrs of being a PPHM shareholder does this to me, there were so many holes in the package that the FDA decided it would be better to send written notes on what needs fixing before they will meet face to face, because a face to face would be too premature due to the work that still needs doing. Or even worse - that the data is questionable maybe due to the India outlier numbers, and the FDA is reviewing it all and may decide that they want to see another ph2 in US only sites. This is just my pessimistic side talking - again, I have reason to think this way after all these years of dios's, signal seeking trials, CTL, china subsidiaries, govt contract extensions... Etc etc

A few more weeks of bouncing between .90 - 1.05 and the BB's will have tightened up again. So far we're in early-mid Nov 2010 stage of finding a bottom...as long as that .85 close holds. We have Seasonality going for us since Dec/Jan is usually good to PPHM so I guess we'll see. The shorts must seem to think that with everything PPHM has going on - multiple trials pancreatic, NSCLC 1st line, 2nd line, IST's, Cotara FDA wait, HCV data... I guess they're thinking at least one of the 5 - 10 near term catalysts will be negative, and it only takes one negative to get crushed, even if it isn't warranted. Like HCV...a sideshow to many while Bavi for AC is the main attraction...they'll crush us if something not as important as, say, the NSCLC 2nd line results, aren't great. Of course, I am here because I think at least one of these catalysts will be successful and lead to an approved indication. PPHM has so much going for it - the multiple cancer trials, Imaging possibility, Cotara, HCV... Not a one hit wonder. Institutions buying, top scientists joining, Thorpe headlining major presentations/conferences, finally analyst invitations...nice to see all of this. Now we just need to take care of this dollar stock price.

Just some random thoughts here while we wait We got one of three expected catalysts so far. Would really really really love to see either a Cotara partner deal, HCV deal or Imaging deal within the next couple months. Would love it if RRdog is right, and we get some good upfront cash so we can suspend the ATM. Not holding my breath or getting hopes up...since they've been crushed for 9 years. Would rather be pleasantly surprised to the upside if mgmt can actually make a money deal, rather than letdown...again.

[RRdog]

Entdoc,

You have to be careful to manage your expectations with PPHM since they are reticent to share information and the information they must share is often poorly worded by their PR people.

I think PPHM had telegraphed a meeting in the fourth quarter with the FDA which morphed into a virtual meeting with written iterations. PPHM did not promise hard information beyond that or an FDA decision.

I share your impatience and IMO there is high probability of a positive FDA decision in due course. IMO the FDA is not in the business of blocking a reasonably based Phase III and Cotara seems to meet that criteria since it passed all criteria in Phases I and II and has been granted orphan drug status and is very PC with the new NIH delivery method.

I think the negotiation is about the protocols such as size and length of the Phase III, what the end points are exactly, what the geographic and patient criteria will be, etc.. It may take a little longer if PPHM involves potential partners in the negotiation (for their viewpoints) and if PPHM presses for the SPA.

It is important to get the Phase III approval with "reasonable" protocols so that potential partners are confident in eventual success. Garnick has demonstrated an ability in other drugs to get protocols with which the corporate sponsor can be successful.

The one change from the PPHM side that I can see is that they now seem open to domestic partnering as well as international partnering. IMO this is a step in the right direction and more in line with PPHM corporate "identity" (PPHM has no marketing expertise and this is a highly specialized market). The more shots at partnering the better I like it.

Regards,
RRdog

[cjgaddy]

PPHM Corp. Factsheet updated 12-14-11 on the website – includes these updated comments the COTARA program:
http://www.peregrineinc.com/images/stories/pdfs/fact_sheet_12-14-11.pdf

PHASE II COTARA PROMISING SURVIVAL DATA
Our novel single-treatment brain cancer therapy Cotara has demonstrated positive median overall survival data of 9.3 months (40.6 weeks) in a Phase II trial in 41 patients with recurrent glioblastoma multiforme (GBM). To further advance Cotara’s clinical development, we have opened a dialogue with the FDA to determine the critical elements of our pivotal trial protocol, which we expect will support our partnering discussions to advance Cotara’s development.