Avid Bioservices Inc (CDMO)

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The Abstract of the ASCO Abstracts!

Yesterday the ASCO abstracts were released. Here is a copy posted by FTM..

As usual the board has commented and as usual there is new information if you read the details. The market didn't react in after hours (a simple 950 shares trade moved us 3 cent down but in that volume is not related to any evaluation of these abstract and if it is it is totally insignificant). Pros and other market participants are for sure browsing tons of these ASCO abstracts and will try to measure the sentiment related to them before trading the related stocks, including PPHM. So today we will see the pss of many involved stocks react. This may not always be within expectation because we know games are played with the pps, PPHM included.

So the assessment at real value of these abstracts is more important then the related pps moves because it will give us better grounds to evaluate our expectations of the poster presentations, that will no doubt as it was on Sept 7th disclose even more details. I'll point some out that we already know now, thanks to these abstracts, in the text below.

I'll start each section with Bavi's safety because I can write the same thing over and over each time and it is the MAJOR criteria for the FDA. Safety problems would/could means NO BTD, no AA's, possibly not even any further clinical trials at all.

Pancreatic Cancer
This clinical trial proves again and confirms consistency of Bavi's excellent, not just good, safety profile.

G+B was well tolerated
...
Most AEs were grade 1-2 and typical of exposure to G (G=Gemcitabine)

For the rest this abstract is, from where I stand, a disappointing one. It doesn't emphasize the big disadvantage of the Bavi arm vs the Control Arm when it comes to enrolled ECOG 2 patients.

We have that information from previous PR and I assume they want to 'unpack' that as the surprise during the presentation which I think will mainly focus on that aspect. Outperforming the SOC by a few weeks and excellent safety is insufficient so the ECOG 0 and 1 details must be the revelation for pancreatic.

Unfortunately this abstract is one of those confusing and disappointing ones in good PPHM 'non-communicado-skills' tradition.

Results: Of the 70 (G/G+B 34/36) patients randomized, 67 (G/G+B 33/34) received study treatment and 63 (G/G+B 31/32) were evaluable. No significant difference was seen in age, gender, race or ECOG.

How much more confusing can you be with that last phrase? Maybe doctors understand it but this abstract isn't investor grade. Are they saying Bavi had the same effects on ALL types of ECOG patients, and actually the ECOG 2 patients died because they were too sick or near death to begin with?
Are they saying there was no significant difference when analyzing the mix of age, gender, race and ECOG in the arms (which we know is not so for the ECOG if the PR and info on pancreatic is correct)?
So we'll go for the first solution for now!

G+B was well tolerated and demonstrated moderate activity in tumor response and survival.

I have been posting many times that you don't go to ASCO to present your failures. The above CT is for sure not a failure but, personally, given the above conclusion of 'moderate activity' I would say that if it is all there is it isn't worth spending money in setting up this Poster presentation.

So there is something they are not telling and also not hinting at here and we'll have to wait for the presentation to find out what it is otherwise it is a waste of our investors money to present this.

Lung Cancer - 2n ln NSCLC
This clinical trial also proves again and confirms consistency of Bavi's excellent, not just good, safety profile.

The safety profile for 3 mg/kg B+D was similar to that of C in severity and frequency. No other safety signal was identified.

The above is for sure not a surprise, we are getting used to this excellent safety profile, but this clinical trial, despite the dose switching incident by our CRO, is going to be a surprise.

ECOG 2 was 13% in C and 24% in 3 mg/kg B+D arms.

Now this is a game changer! We have NEVER in the past had this information unless I am mistaken. As entdoc posted people reading results are not just reading numbers in an unrelated way as most of us do. They correlate information and all numbers will NOW be placed in perspective of the knowledge that there were almost double the amount of very sick patients in the 3mg Bavi Arm then there where in the Control arm.

That means that the EXCELLENT results 2nd ln NSCLC had, even after the dose switching, were achieved with a BIG handicap for the 3mg Bavi arm due to patient randomizing (and lets assume this is REALLY by coincidence and not a second strategy related to the dose switching to also affect the 3mg Arm, if you understand what I am saying).

But incrementally more important, hence probably entdoc's emphasizing on this ECOG information, is that if C has an ECOG of 13% after joining the control arm and the 1mg Bavi arm together, the conservative FDA-grade approach part of the salvaging of the dose switching, then it must have been <13% for the original control arm alone. In other words the control arm was extremely put in the ADVANTAGE when we announced our 100+% MOS improvement. This trial did even better then we all thought! If we would assume, because we cannot know exactly, that the 13% is 50/50 in origin from both arms then the control arm had only 6.5% ECOG 2 patients or almost 4 TIMES LESS then the 3mg/arm that achieved 100+% MOS improvement.

Another important new peace of data is that at analysis time of the last announced results 54% of the patients in the 3mg Bavi arm evented. The board has speculated a little about what this could mean but I will look at this information in combination with SK's statements.

Oct 6th 2012 was the 1-Year Survival date as of the last enrollment date (give a few weeks if there was a delay between enrollment and start of treatment), make that Nov 1th, 2012.

For June, and KT was correct in his post, we received the information that the MAJORITY of patients was still alive by a statement of SK some moths later. Assuming the analyzing date for the Feb 2013 PR was closed JAN 2013, then 3 months after the 1-YS still 46% of the patients in that 3mg arm where alive.
That means that WITHOUT ANY POSSIBLE DOUPT 46% of the patients made it PASSED NOV 1th 2012 and that the Bavi 3mg arm for one of the VERY DEATHLY cancers managed to keep 18 patients out of the 40 alive for at least 15 months!

And here also, the 71% death in the combined control+1mg arm would have been higher because this arm has had the advantage of Bavi treatment due to the dose switching compared to the control arm with its low number of ECOG 2 patients that would NOT have had Bavi treatment.

So, as I have used the worst, non speculative, case for the above reasoning I think EYEBUYSTOX may be correct if he claims 50% and possibly 50+% of 1-Year Survivals, but that needs to be confirmed in the presentation. Anyways, 46% for 15 months is a small miracle on itself and will do for me!

Last but not least I would also like to emphasize the line biopharm already bolded out!

No other safety signal was identified. Conclusions: This randomized, placebo-controlled phase 2 trial demonstrated a positive trend favoring 3 mg/kg B1D in ORR, PFS and OS. 3 mg/kg B in combination with D was well tolerated and is the planned dose for Phase 3.

My attention here goes mainly to "3 mg/kg B in combination with D was well tolerated and is the planned dose forPhase 3."
This is a more important statement that one would first think. I think we all knew the 3mg Bavi arm was the PIII candidate, so nothing new there.

However, it is the un-smoothed use of the words "and is the planned" that interests me. It is unlike Peregrine to use such clear wording. One could have expected "and is a possible or probable candidate for PIII!"

The author of this peace of text has written something based on his knowledge of facts not thinking that the used formulation is disclosing that Peregrine PLANNED the PIII for a fact (because that is what the investors community will read and is/has been told now to make there investment decision on).
It does not say maybe planned, or to be discussed with the FDA and on there approval planned, or proposed as a plan to the FDA in the EOPII meeting, ect. - no it says plain and straight forward : "is planned" as if they KNOW the result of the EOPII meeting! It also gives away we should NOT expect a BTD for 2nd ln NSCLC otherwise why plan a PIII.

While due to the dose switching case we may have looked at this trial as somewhat crippled I think it is alive and kicking and will kick harder then on the Chicago Sept 7th 2012 conference. If it wasn't for that Breast Cancer abstract I would have indicated this presentation as the PPHM event for ASCO.

Breast Cancer
And again a clinical trial that also proves and confirms consistency of Bavi's excellent, not just good, safety profile. The previous PII Breast Cancer CT did too.

Bavi related toxicities include grade2/3 infusion related reactions in 2 pts (1 discontinued Bavi). Bone pain, fatigue, headache and neutropenia were the most common adverse effects. 1 pt had a catheter associated upper extremity thrombosis requiring anticoagulation.

The catheter problem is not Bavi specific it has to do with catheter use in general, hence not really a problem. Nothing that kills you in this list! Apart from the safety it looks like some patients don't tolerate this cocktail or tolerate it less good.
We are talking about 2 on 10, or 20%, of which some (10%) seem to be able to continue the treatment never the less. But of course this sample is insufficient to draw these conclusion in general.

But I think we all know that concerning this abstract nobody was actually waiting for safety information but we all would like to know why they present this at all to begin with. This is a PI clinical trial that isn't even finished!

The first thing we learn is that we are far behind the 5 initial patients and that, as expected and posted in one of my posts a few days ago, they must have seen something on more patients in between that 5 patients info and the PR of a few weeks ago announcing total enrollment. They had to file for this presentation long before that!

This abstract confirms it. 1 (C)omplete (R)esponse, 6 (P)artial (R)esponse, 1 (S)table Disease, 2 (P)rogressive Disease (let's exclude the 4 others because there is no valid info yet, to early).
Does anyone has an idea what this means! 8 out of 10 patients on such SMALL sample have the tumor growth stabilized and stopped, shrinking or completely disappearing.

That means that if these patients are alive and in a condition that can sustain there live at the beginning of the clinical trial they should NOT get worse (1), get better (6) or cure (1) and therefor we may assume they stay alive in the same or better condition then before.

If we have comparable results with the 4 remaining patients in this trial then it will be hard to reach the MOS event due to patients dying from the progression of this Breast Cancer because with 80% vs 20% it will be hard to have 50% of them to event!

Based on the above I now say even more and louder that Breast Cancer is our BTD candidate and it would be irresponsible of PPHM not to have filed for it!

Conclusions: Bavi is a novel vascular targeting agent that is well tolerated in combination with P. Early results show promise in terms of clinical responses with 8 of 10 evaluable patients having clinical benefit.

So this conclusion doesn't surprise me and the 8 out of 10 is why we are presenting this at ASCO! The only additional thing that we need to get this in the BTD program is/was production capacity. I think it is clear by now from Garnick's last CC comments and Avid's sudden metamorphosis into a knowledgeable ahead of state of the art manufacturer of Bavi that production is being dealt with, if not already in stand by.

Conclusion
Finally our boat is moving forward with more then one propeller. Abstracts that seemed to hold no news at first glance contained a lot of new information when looked at in detail with the exception of the disappointing pancreatic cancer abstract.

The nice thing is that we will not have to wait for the full disclosure this time. The ASCO even is in two weeks. PPHM is not pushing event dates to the future anymore. They clearly seem to have their game together this time.

It is the reward of paying and long waiting to allow them to gain experience and keep IP and pipelines in our 100% unencumbered control without the pressure of depths and creditors.

We'll have the ATM to thank for the fact that the small investor, and not only the bankers, funds and BPs, are going to participate in the huge leverage the Bavi and Cotara pieplines hold in them!

No matter what the pps will do, we are good. So the message for those with the intention to stay long is to make sure you protect your stops. We may see a peek today to move your trailing stops up and then claboom a deep dip to make them go off.

That would be within expectations because we've seen these averse market reactions after positive news several time. I have no stops for that reasons as I don't want to buy back my shares in competition with intra-day shorters covering their positions.

I would like to close with entdoc's statement about these abstract in the current stage of information available to us:

Not a home run, but methinks there we have a runner in scoring position.

The Home Run, in good tradition, is reserved for ASCO.