Replies to post #100203 on Avid Bioservices Inc (CDMO)

[volgoat]

Do you think they believe it was sabotage?
Would not surprise me at this point.

[learningcurve2020]

Did you forget about this article?
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

[eastcoastguy]

Doc, certainly a concern of mine in examining all the trial sites. I did see that the pancreatic cancer trials were predominantly done in the US (15 sites) Ukraine (4 sites). But our 2nd line Lung that blew up had alot of Indian sites and a fair amount in Russia. Though all BP's use foreign sites to save money...its no secret that controls and oversight are not always tight.

Special thanks to you and others for reporting back your thoughts of the ASM

[eb0783]

Wow Doc. That is the stuff movies are made of and I took your story as a parody. It sounds like a spy novel. I’m not sure where that last half of it came from though. Are you sure that last beer was not too much fer ya? …or did you have some of Loofman’s stash? :-) I did not gather anything like that from what I heard. Although I will admit that your medical background may well have your mind keying on things that I don’t hear at all. So no disrespect because you certainly have mine.

[md1225]

Entdoc most of MNKD Afrezza trials have been done overseas if Im not mistaken with no problems at all. Medicine practice abroad Korea and Germany which I have seen first hand is as good or better than US. There is something to be said for socialized care. As for India/Eastern Europe I don't know. It all comes down to money. ISTs are prgressing in US and we should see the same consistent results.
Again if Bavi works Big pharma wants it. Big Pharm X is not going to see if Big pharm Y buys 1st.

[stoneroad]

entdoc, I'm a tad confused. In ready your prior posts about the SHM, I felt that you came away slightly encouraged. With this latest post, it seems you are intimating that the Bavi 2nd line nsclc trial is a complete bust. What gives?

[nuke661]

Entdoc,

Your posted:

Did anyone else get this? Here's a direct transcription from the ASM:
"PII pancreatic ca w gemcitabine
not clear how drug was tracking.
similar results in both [testing sites???]
discordant response in two groups
differences in central read [foreign centers?] vs. local hospitals… put off interpretation
MOS to be reached late this year or early next year. Too early to tell .
Pancreatic: completed enrollment June this year.
Primary endpoint MOS? “WHEN? end of this year or beginning next year

This had me concerned that you were hearing that the pancreatic trials may be exhibiting/generating the results stated such as: discordant response, difference in central reads.

This drove me to listen to the webcast again and this is what I heard (starting around the 4:30 mark). The discussion regarding the "not clear on tracking and discordant response and differences in central reads" issues were all associated with the front line NSCLC data that was presented earlier this year. This was the data that a number of entities jumped on as indication that bavi was ineffective. But I believe that info was followed up with a discussion regarding how the typical/historical indicators may not be accurately reflective of a drug that may have a longer MOA. This previous sentence I'm not that not that clear on; people will have to listen to it themselves to be sure.

Anyway, I'm good with the fact that there was no information provided in the webcast portion that indicates anything potentially off kilter with the pancreatic trials. Which for me is good. The pancreatic trial is the trial that I'm hoping/guessing will play a major factor (not to be confused with the only factor) in re-establishing positive momentum in the shortest time frame possible. It would IMO significantly boost the information to indicate that Bavi has broad based application by showing efficacy in yet another high unmet medical need.

Another interesting thing I heard in listening to the recording was around the 18:50 mark when Steve K. stated "...complete the investigation OR report results from that 2nd line NSCLC trial..."

He also stated near the beginning of his talk (didn't write down the time mark and I don't have any desire to go back and find it) that the 2nd line NSCLC was the primary target and still a "Potential" lead indication.

These statements are saying to me that they definitely aren't ready to broadcast that they've given up on reviving the data with what they currently know. Nor does it indicate to me that they have a ton of confidence of achieving that goal either. For what its worth.

Thanks again for the first hand information that you and the others that attended the ASM have been providing.

[Tech Writer]

ENT Doc,

I have many years of experience as a print journalist covering a specialty field in clinical practice--not clinical trials, but medicine. I've interviewed a gazillion doctors in my time, and I've sat through probably hundreds of presentations where I was required to accurately report in print, without bias, what I saw and heard. (The blurred lines between hobby "expert" bloggers and true journalists really pisses me off, but I digress...)

Now I could certainly be wrong, but I DID NOT hear what you're suggesting. You're well respected on the board, and let me state up front that I do not doubt your sincerity. I'll just try to set the record straight from my perspective, which is all any of us can do.

I believe your notes are confused/jumbled between trials. You wrote:

discordant response in two groups
differences in central read [foreign centers?] vs. local hospitals… put off interpretation
MOS to be reached late this year or early next year. Too early to tell

At that point in time, I am personally confident that they were discussing the front line NSCLC data that was PR'd in March --something already made clear to investors and the medical community.
This from the March press release on the FRONT LINE NSCLC trial...

"While the data from the investigator assessments were in alignment with previous published reports for carboplatin and paclitaxel and suggested an encouraging difference between the treatment arms, the unexpected long PFS estimate for the control arm based on central reads confounds our ability to fully interpret this secondary efficacy endpoint," said Joseph Shan, vice president, clinical & regulatory affairs at Peregrine. "We now await median OS data from this study which is the most clinically relevant endpoint from a drug development standpoint."

While I enjoy this board, one of the more frustrating things is the incessant reading of tea leaves that takes place--trying to gather, surmise, cling to, construct, etc., "evidence" of one's particular point of view, conspiracies, etc. Frankly, it's exhausting. Both the shorts and the longs are guilty of this nonsense.

From my perspective, they made it entirely clear that whatever SNAFU occurred in the 2nd line NSCLC trial is to their knowledge in no manner related to the other trials in progress. And I did not in any way hear that the specific problem with this trial is tied to activities at the foreign sites.

Investor relations, if you're out there, this is exactly why you need to communicate loudly, clearly and often with your shareholders. If you do not present the facts in black and white, and repeat them many times, they will create their own. (You're unintentionally "feeding the bears.")

Could there be some broader problem with the foreign sites? Hey, anything is possible with Peregrine or any of the hundreds of other biotech/pharmas that utilize these sites. Are there inherent problems with utilizing foreign sites? Perhaps. Should the industry as a whole reconsider the wisdom of using foreign sites? Perhaps. Could a foreign site end up being a problem? It's not outside the realm of possibility. I just don't think that he was at all intimating, suggesting, revealing, hinting, etc., that this is a specific concern with the second line NSCLC trial or any of their other trials.

I would strongly suggest that you reach out to IR and pose your question directly to them. Let them tell you straight up what was or wasn't said. Contrary to what some would suggest on this board, I don't think they're in the business of intentionally deceiving investors, and I believe they'll try to provide whatever information they can. Give yourself that peace of mind, and then share it with the board.

I would be interested to hear if anyone else who was in the room has similar concerns?

And no, I don't think anyone at the company is lying or hiding anything. They pulled the rug out from under themselves in the most spectacular fashion. I believe they are eager to fully understand what occurred, and will report just that when they have all the facts in hand. I don't waste my time constructing scenarios of misconduct among senior leadership. Anyone who does should probably invest in another biotech or get out of this risky form of investing all together.

My comments are not directed specifically to ENT Doc. Again, let me reiterate that I don't at all doubt his sincerity.

This investigation cannot be concluded soon enough.

This is, of course, just my opinion.