Replies to post #263262 on Avid Bioservices Inc (CDMO)

[cheynew]

I'm sick of those claiming management is in no way responsible for where we are today, at +/- .35. It is disgusting the mismanagement of huge $$ over the years and their claims "it certainly isn't OUR fault!" It was on their watch and clearly they aren't watching or planning for negative results. They should have partnered years ago and let capable people handle these trials. I don't believe every BP would just put Bavi on the shelf and let it rot. They could do no worse than this team has.

[The Other Guy]

It raises serious questions as to certain motives, doesn't it?

[bfiest]

Everyone here has different time horizons, monetary capabilities, motives etc. You have to do what is right for you. Your questions are spot on Loof and represent the feeling of the majority of long held retail shareholders. I am hoping this management team turns this around. There is nothing more than we all want than to support them in their efforts assuming their efforts are in alignment with the needs and desires of the current investors of this company. But to believe that we have no course of action if they continue with further, unlimited dilution and no real results is, at minimum, highly underestimating. Let's hope they move the ball forward this time and show us they are working in our behalf. Status quo will not be accepted any longer. Assuming Bavi works, they have the tools and the ability to win this game for all shareholders right now. We need to see results, not more of the same.

[Protector]

Loof, decent questions deserve decent answers.

CP, I think you should go to find out why management has spent millions of dollars on trials that either were put on the shelf, were mishandled and failed before first look in because of futility.

We have seen, and the analysts even phrased it in Q/CC questions, that more and more companies seem to suffer this phenomena.Remarkably it are mostly Small Cap Biotechs! Equally remarkably the FDA maintains a regulation that makes it possible as if it where designed to manipulate.

- Randomizing per ECOG/STAGE is a simple and straight forward manner to avoid what happened to our Pancreatic, yet the FDA still requires randomizing per arm.

- Blinding is good, blinding the sponsor allows for all kinds of CRO manipulations. Putting a communication embargo, within certain boundaries, but authorizing the sponsor to 100% audit and in-field post-audit (=verify is a used vial contained the expected substance) would be equally efficient. Now sponsors derive/anticipate results with simulations (they have some more data then we do to do it :) and they are vulnerable to all kinds of fraud.

- The SOC to beat should not be the control arm (and clinical trials would be cheaper without the control arm) but would have to be the performance of the SOC based on which it got approved, possibly corrected yearly or 3 yearly to accommodate for other care factors. Take the chance factor out of it, the only reasonable thing to do when you are dealing with lives. Unfortunately we know lives have nothing to do with it, in that industry money is the only rational and money corrupts.

So blaming these things on PPHM is I think no serious, they colour between the lines. One could at the most say that PPHM should know/have known that they didn't have any chance to do this alone (if that would be the case - just saying) and they should have partnered.

You should go to ask why there was no significant plan B ready to be in place after failed Phase lll trial which to this day has still not been revealed.

That is to early to say. We have the IR company that announce to bfiest that PPHM isn't a single trick pony (so there may be a plan B) and if it is not announce there may be strategic reasons. I think the next Q/CC is reasonable, it would, IMO, not be wise to announce today to the public that you stop SUNRISE and 4 week later without knowing what really happened tell them plan B which you may not have to execute. And as an example, and I know it is controversial and will entice bidrite into further quasi-aimed comments on the subject, but : WE DO NOT KNOW WHAT EXACTLY WAS WRITTEN IN THE SUNRISE PROTOCOL IN RELATION WITH THE IMPACT OF OPDIVO/KEYTRUDA COMMING TO THE MARKET BEFORE SUNRISE. We know some guarantees have been obtained (Garnick & Shan) but was this only related to a possible SOC change or did it include impact of 3rd ln treatment and was there any opening to fall-back on PII+salvaging data + 3mg/Kg arm of first or 2nd look-in? We don't know.

You should go to ask management why they put all their eggs into one basket into an area where the signs were showing combinations with chemo were a declining area of potential and immunology was where science is heading.

Loof, you can ONLY make this statement with hindsight. Sorry, but in 2012 there was no I-O hype. It started at ASCO 2013 as a first hype. But then apparently of an FDA Director's wife gets cancer suddenly things are possible and not so long after Opdivo/Keytruda where approved.

There wasn't even an approved I-O drug when PPHM got SUNRISE approved, let alone all the months before when the prepared, filed and waited for that approval. And Loof remember, actually there was NOT going to be a PIII SUNRISE. The PII was a double blinded placebo controlled multi arm registrational clinical trial, the one that made CEO King say he expected a product on the market mid-2012. So you could ask many BP's why they missed the I-O train? Only a handful of them, say 4-6, are sufficiently in it and 2 are successfully (=meaningful revenue) in it.
So your expectations of what PPHM should have seen are even behind that of most BP's.

There are at least 20 years worth of questions to ask of management in regards to creating shareholder value which management has stated it was attempting to do over all these years. The result ... 20 years later...
the vast majority of long term shareholders have lost on paper or in realuze losses 70, 80...90% of their investments under Peregrine managements ineffective control.

Now this is a chain reaction. yes, the facts are correct. management based on what they started have, several times, mentioned shareholders value. The events that were VERY LIKELY to happen did happen and hence the related revenue (=shareholders value) didn't come. But you are digging into a DEEPER problem here. PPHM's Management should ask questions about the statistical significant amount of bad luck they had here. In 1st ln NSCLC, 2nd ln NSCLC, SUNRISE and Pancreatic they EACH TIME see good to super good performances of Bavituximab that in a safe way betas the historical SOC and/or the control arm SOC, but due to some reason cannot translate those Bavituximab performance into approvals. Yet we have NO SIGN of any official complaints or requests for investigation related to this, certainly after PPHM tried to extend its law suite against CSM to FRAUD. It is as if every company in that industry is afraid to walk on the FDA's toes. Maybe some more aggressive coordinated action with other small cap biotechs would be advisable.

You deserve better, we deserve better. We all deserve transparency and honest answers as to how management plans to take the company forward in a measurable way that shows investiors fudiciary responsibility towards its shareholders. This does not include increased salaries, bonuses and cheap options.

Yes for transparency within the boundaries of strategic possibilities. PPHM remains a commercial company with competition. Of course yes to honest answer as long as you were not implying we have been given 'non honest' answers, because IMO everything PPHM has communicated was honest at the moment they communicated it. Something not turning out as they expected is not the same as dishonest. The salaries must not be increased, past options must NOT be renewed (that would bypass the complete idea of options that have a TIME STRESS forcing option holders to perform in the short term). New options should be awarded because they are part of the compensation packets and because we have all interest that BoD/management and employees see big POTENTIAL parts of compensation based on high PPS because we want a high PPS too. As for bonuses, well they be based on clearly upfront defined goals that are either achieved or not and bonuses paid accordingly. So if starting Avid II in the FY was a goal then they deserve the bonus. If SUNRISE was one that they loose the bonus. Bad luck for us, back luck for them.