Avid Bioservices Inc (CDMO)

[nuke661]

PPHMVERYLONG,

As a follow up to my post to you last night regarding the importance of performing due diligence research I'd like to provide the following as a brief example of where I think your due diligence is coming up short.

You stated:

You are forgetting the pancreatic cancer trial that was supposed to be the confirmation trial to lung cancer. Celgene succeeds, PPHM fails, that was the headline.

First, for some reason you've stated that the pancreatic trial was supposed to be a confirmation of the lung cancer trial. I'd like to prove you wrong on this but, because Peregrine never said such a thing and no one on this board (from the group that I believe actually performs research as part of due diligence) has ever said this, I can't prove this negative. The pancreatic trial was an attempt to research the breadth of applicability and efficacy of Bavituximab as evidenced by the following statement made by Steve King:

"We were inspired to conduct this study based on the encouraging and consistent signs of bavituximab's anti-tumor activity across multiple oncology indications as well as the promising preclinical data supporting the potential of bavituximab in combination with gemcitabine in advanced pancreatic cancer models,"

If the company ever said it was to confirm lung cancer then please provide a link.

You then stated "Celgene succeeds,PPHM fails, that was the headline.". I can only assume that this statement was an obvious attempt at hyperbole and/or humor because obviously there was no headline stating such. If there was I apologize in advance and my mistaken perception could have been avoided if you provided references/links to confirm you statements.

The fact is that the Abraxane and Bavituximab pancreatic cancer trials were performed on entirely different classes of pancreatic cancer patients with significant differences in inclusion criteria and treatment regimens. These difference, when evaluated with a modicum of intent to derive factual evidence of the quality of the performance of each drug, make a very significant difference in the expected outcomes. In essence, comparing the Abraxane trial to the Bavituximab trial is, in my opinion, like comparing apples to oranges. I will provide a basis for my statements with references and links to credible sources to back up what I say.

Along these lines, your postings certainly seem to lack reference to factual and credible sources. I'd like to caution you that to be taken seriously by your fellow board members here that you should try on provide references/links to back up your statements. I will be providing examples of that in the rest of this discussion so that you can have an example to work with in the hopes of gaining a basic understanding of what due diligence looks like and how its presented on a board such as this.

The pancreatic trials for both Celegene's Abraxane and Peregrine's Bavituximab are posted on the clinical trials.gov website. Also, the website for the National Cancer Institute has a detailed website providing information on pancreatic cancer such as how the cancers are graded, treatment regimens for the different classes (stages) of the cancer the, expected outcomes for each stage, etc...

Here is a table comparing the two trials' criteria which represent significant markers for the expected outcome such as long term survival rates and expected duration of survival for pancreatic cancer. The links to the clinical trials.gov websites for each trial are embedded in the column heading on the table for each trial.

         
 Comparing Peregrines Pancreatic Trial to Celegene’s Pancreatic Trial 
  
 Trial Criteria	   Bavituximab (Peregrine)      Abraxane (Celgene) 
 ECOG Status	      ≤ 2	                          ≤ 1 
  
 Stage	                4	                          ≤ 2 (1) 
  
 Surgery as 	        No	                          Yes	 
 Part of Study	

(1) Although the cancer stage criteria is not clearly stated in the Abraxane clinical trial link (provided above) the Abraxane inclusion criteria clearly states that the cancer has to be “potentially operable”. From the National Cancer Institute’s site for pancreatic cancer the stages 1, 2 are operable and stage 3 is possibly operable for palliative care. However, stage 4 is considered inoperable. Continuing, Table 4 and 5 (in the NCI link provided) provide definitions of pancreatic cancer stages 2 and 3. Table 5 (stage 3) includes when the tumor involves the celiac axis or the superior mesenteric artery (unresectable; i.e., non-operable). Now going back to the Abraxane trial on the clinical trials.gov website (link provided above) the inclusion criteria clearly states that “No extension to superior mesenteric artery (SMA) and hepatic artery”. So, with all the other Stage 2 (Table 3) and 3 (Table 4) criteria being the same, the Abraxane inclusion criteria sort of clearly, in a round-about way, states that only stage 1 or 2 patients are included in the Abraxane trial.

Now referring back to the NCI website (link provided previously) when one reads the details associated with the treatments for each stage it becomes quite evident that there is a very clear and significant difference in the expected outcomes for stage 1 & 2 and stage 4 pancreatic cancers. It should also be noted, and is discussed in the NIC website only about 20% of pancreatic cancers are discovered in stages 1 or 2. Also, the best that can be hoped for according to NIC is only 18 to 24% of patients are expected to achieve a 5 year survival:

The highest cure rate occurs if the tumor is truly localized to the pancreas (this can only be stage 1 and 2 per definition tables 3, 4 and 5; comment by NUKE661); however, this stage of disease accounts for less than 20% of cases. For patients with localized disease and small cancers (<2 cm) with no lymph node metastases and no extension beyond the capsule of the pancreas, complete surgical resection is associated with an actuarial 5-year survival rate of 18% to 24%.

The Abraxane trial was less than five years as can be determined from the clinical trials.gov website (link previously provided). From the Abraxane drug insert the number of long term survivors was 331 out of 431 total, ~23 %. The gemcitabine control group 359 out of 430, ~17 %. One can readily see a couple of things from these numbers; 1) the Abraxane numbers are within historical expected long term survival (and remember the trial data doesn't actually cover the full 5 years, only about 4 years) so the numbers for long term survival can actually be, and probably are, lower in the expected long term survival percentages) and therefore does not represent any significant improvement in long term survival, which I'm sure is what everyone really wants and 2) the gemcitabine control group was slightly lower than the historically expected long term survival.

Therefore, although Abraxane had a significant increase in median overall survival (8.5 mos vs 6.7 mos for the lower performing control group), its MOS performance was not indicative of any significant increase in long term survival.

In summary, Celgine and Peregrine went after completely different categories of pancreatic cancer. I wouldn't consider Abraxane's performance anything to write home about but because all pancreatic cancer has such an extremely an extremely poor prognosis with very small percentages of long term survival. Abraxane went after the lowest lying fruit and made what I would consider a very small improvement in MOS and no improvement in long term survival. But, because they are a BP they can afford to obtain approvals for any drug that shows improvement and represents an increase in some market share. Peregrines performance in stage 4 was modest but it was against a by far more difficult to treat population. Also, Peregrine doesn't have the resources (yet) to pursue this indication at this time and as they have indicated they would probably pursue this as part of a combo treatment regimen which only makes sense to me.

It has taken me about an hour to find this info and write this post. I believe this post to be an example of what basic due diligence research involves and how it provides a basis for a factual discussion for the benefit of all. I hope this helps clear up some of your obvious misunderstandings about the Bavituximab pancreatic trial and I hope it removes some of the non-factual information that seems to constantly appear on this board regarding that trial. I hope one day you return the favor with links to factual and credible references like the ones I've provided to help support you statements that you regularly make here on this board.

Its a great day here and I hope you're having a nice day where you are.