Avid Bioservices Inc (CDMO)

[Protector]

2nd ln NSCLC more secrets revealed

We were without any doubt all very happy when PPHM, after the dose switching incident in the 2nd ln NSCLC clinical trial, announced that it salvaged the trial and got an FDA PIII design approval.

While we may have felt fully informed about the frame-work in which the FDA made this approval it is clear that at least two pieces, and actually now 3 pieces and very probably even 4 (i'll come to that) have been kept from the retail share holder.

It took a slip of the tongue of Shan to find out that the FDA granted an interim look-in for this trial.

It then took the mangling on the annual to 'non-officially', rumour grade, find out that there seemed to be/could be a second interim look-in. However, this piece of information was only confirmed to a very small group of people through information send out in offerings for the preferred shares by MLV, listing it as a reason why one should subscribe to the preferred shares. Several posters of this board made the MLV request and got the reply with that information.

It then took a surprise Fast Track approval by the FDA to find out PPHM requested a FT for this trial. Ok I can understand that PPHM may not have announced that and waited until granting. I'll give them that.

In the same line it is ALMOST SURE they applied for an AA (Accelerated Approval) because there isn't one common sense argument that one could bring froward why they would not if they already satisfy the conditions for it to be granted (Super PII results FULLY compliant with the FDA guide-lines for AA approval, applying possible as of start of the PIII which they did start in DEC 2013, a Fast Track which they have now since JAN 2014, and interim look-in possibilities allowing the installed supervision committee to stop the trial early as is mentioned in the trail specification, of which they even seem to have TWO now).

For Cotara they PRed that early trial stop possibility while for Bavi 2nd ln NSCLC they kept it well out of the official communications.

But why is the OFFICIALIZING of the second intermediate look in so important for us investors to know? Well, here is why I think it is.

PPHM and the FDA agreed on an two arm n300 SOC+Placebo & n300 SOC+BAVI 3mg/Kg Double Blinded CT.
If you have one interim look in you expect it around halve way the clinical trial (about 300 patients enrolled and treated + some follow-up time).
If you have two interim look ins then you would expect them about 1/3 and 2/3 of the clinical trial.

1/3 means 100 SOC+Placebo and 100 SOC+BAVI patients.

Now, you have to bring the above into context.
- Shan mentioned PPHM's intend to do a Hockey Stick enrolment
- PPHM added 2 treatment centres at start up in DEC 2013, 4 in JAN 2014 and 5 a few days ago FEB 2014 for a total of 11 centres.

So we are down at 200/11=18 patients average per centre FOR THE MOMENT, that is about 1.5, say 2, patients per months per centre, in order to unroll them all this year. If we have to believe some who's name we do not speak we had already 7 patients enrolled with our TWO initial centres in DEC to JAN, so we are ahead on schedule :) But can we believe them?

I am sure we'll see plenty of other centres added the coming mounts which will bring that average down. European centres should enrol much faster because SOC (Docetaxel) and generics fall under Social Security Medical Care coverage and hospital cost stays are always covered. Furthermore plenty of people have extra DKV private coverage paying all the remaining costs.

Just adding 10 centres would bring the needed average down to 1 patient per month and that would NOT EVEN qualify as hockey stick enrolment, would it. PPHM anticipated the about 50 centres from PII plus an extra 50 centres.

So it would not be unrealistic to assume there is a possibility PPHM could unroll these 200 patients before Q1/2015 at the rate they are going. Quite a difference with their PII, of course they didn't at the time know what they know now, neither did the Doctors and patients. Furthermore AVid has those new production means for more, faster and cheaper Bavi production in their own facilities or 3RD parties depending on who manufactures the Bavi for this trial.


So the point I want to make is that with a 2nd interim look in and the hockey stick enrolment we could have surprise news from this trial MUCH EARLIER then we think! Certainly because as stated before PPHM has that monitoring committee in place (see clinicaltrials.gov sheet) and they have the Fast Track and very probably will get the Accelerated Approval to QUICKLY follow up on an early stopped clinical trial.

PPHM clearly also ALREADY got all people hired to follow up on as well US as International BLA/NDA (see biopharm's hiring linked-list). Why would they if they anticipate end-of trial in DEC 2016. You are not paying people two years for a job they can do as of JAN 2016 and have a full year plus some time during trial processing, are you?

So question is: Does PPHM discriminate in its information disclosure and gives less or less complete information to the retail share-holders then to professional investors,II's, Funds, etc?

Do they do this because of personal interest for option assignment?
DO they want to create preferred possibilities for ES or ES related companies? Are they just sloppy and have a defect IR/PR policy, possibly even an illegal one?