Replies to post #321803 on Avid Bioservices Inc (CDMO)
01/04/18 12:31 PM
01/04/18 12:32 PM
01/04/18 12:47 PM
My name is ----- ------ and my spouse and I are now forced to send a letter of concern after seeing CEO King resign and shareholders are completely blind to what information the new Board of Directors may have received or more importantly, not received from the prior Board. We have been shareholders of PPHM for many years. I became a shareholder for one reason only. I am convinced that the IP that Dr. Phil Thorpe invented was and still is a paradigm shifting technology. The company may have been mismanaged at times and poor decisions may have been made in the past but you are now at the helm.
Some facts you should be aware of. In September of 2012 the company reported on our most significant clinical trial to that date “Phase IIb Bavituximab+Docetaxel vs 2nd Line NSCLC (randomized, double-blinded, placebo-controlled, n=120, registrational)”. That trial could have led to early approval from the FDA. That trial was mismanaged by CSM as CEO Gerald Finken took over for Jeanette Bleecker that swapped the trial arm at times and along with these court records that were sealed, have you and the rest of the Board of Directors at Peregrine been given due diligence access to all sealed court records and dozens of non-disclosed collaborations, in order to comply with Fiduciary Duties and properly assess the value of the IP ?
PPHM sued CSM and have you read the full transcript of depositions and all court sealed records which must be reviewed and required to evaluate any possible mismanagement by the prior Board of Directors and required to properly assess IP asset valuations that may not have been made known to the public. These sealed court records will further prove Bavituximab could have been approved already.
According to depositions filed in court, we know that PPHM and Abbott Labs (Abbvie) were in negotiations and a deal to be around $2 Billion that included seats on the Board of Directors were being finalized. That deal fell through as a result of CSM’s actions. The company was able to salvage enough data to prove to the FDA that only two of the 3 arms were incorrectly randomized, those two arms were combined and compared to the uncontaminated arm. Ultimately, the FDA approved the Sunrise Phase III trial based on this data. Have you spoken with Dr. Rolf Brekken, as he also spoke at a NYAS public presentation as well after the sabotage was discovered, trial data salvaged and confirmed to the audience that the results of that phase IIb sabotaged trial were “BETTER” than the reported results filed with the FDA for the Sunrise approval. I find it very odd that this was not made public and now with you being at the helm, any and all final determinations of the value of the IP should be put on hold till fiduciary duties have been met, unless much of any fiduciary duty concerns are not warranted and further evidence of that remains to be seen by shareholders, because as Steve King said that the pps is undervalued...many shareholders agree and I sincerely hope non disclosure agreements were not allowed to be signed by current BODs that allows for any loopholes where it made it impossible to comply already in place Fiduciary Duties?
Over the last decade plus, the company ran several Phase I and Phase II trials, including two for breast cancer. In addition, the company initiated 6 IST’s, several of which produced very good data that indicated further trials were warranted. The SUNRISE trial was halted at first look-in but, post analysis indicates that certain patients with specific biomarkers could do very well in another trial with various new immunotherapies and the
Key Opinion Leaders in the immunotherapy field include:
UTSW (Dr Rolf Brekken/Schroit research collaboration)
Memorial Sloan Kettering (Dr. Jedd Wolchok Lab)
The National Comprehensive Cancer Network – NCCN selected 3 Bavituximab trials at Moffitt/Mass General/John Hopkins
Duke University (Dr. Herbert K. Lyerly
MD Anderson (Dr. Jason Fleming)
Rutgers University (Dr. Raymond Birge)
… and many others, all have tested and validated the science.
So why this letter to you?
Basically, many clinical trials have proven that Bavituximab performed as expected by the trial design and every non-approval was always due to control arm problems: 2nd line NSCLC with dose switching in the disadvantage of Bavituximab, Sunrise abnormal Docetaxel over performance and 3rd line treatment became available during the trial, Liver randomizing healthy patients into control arm..etc.
Now this past year, a recent group of investors “The Ronin Group” took a large position in our company. Their goal is to divest the IP and focus on expanding AVID. Most retail investors that I communicate with are not opposed to this transition. However, there is a conflict with regards to the value of the IP. From other investors written and verbal communications with Steve White it appears that their opinion of the IP is:
Bavituximab: A failure
Liquid Biopsy: Maybe
Betabodies: What?
Most retail shareholders do not share that opinion. Hundreds of papers have been written about the immunosuppression qualities of phosphatidylserine and after the sabotage events behind CSM in Fargo, ND… some believe that this may have been targeting against Peregrine Pharmaceuticals, especially now where all prior Board of Directors are now gone and I ask, has the new Board of Directors been allowed access to all information of the past, dozens of non-disclosed collaborations, all sealed court records…etc which all must be considered part of ones fiduciary duties when evaluating a company’s assets.
I bring forth an example below from one way a company’s BOD may not have met fiduciary duties and that would be by not allowing an investment bank, such as Goldman Sachs to seek competitive open bids to maximize shareholder value.
“Goldman Sachs’ Letter to MEDX Board of Directors (BOD) openly acknowledges that MEDX BOD failed fiduciary responsibilities……
We (Goldman Sachs’) were not requested to solicit, and did not solicit, interest from other parties with respect to an acquisition of or other business combination with the Company.”
melanomamissionary. blogspot.com/2009/08/is- medarex-and-bristol-meyer- squibb-in.html?m=1
In conclusion, we hope that the sale of our IP will be an open, multi-bid process that will satisfy the long-term shareholders and provide the new company with sufficient funds to deal with future expansion. The previous management failed miserably when it came to communicating with shareholders and I would like to include that the current Board of Directors also have an Investment Bank look into the records of the change in transfer agents to make sure no illegal activities may have taken place under the direction of the previous Board of Directors. There was a reason why this change took place, also may be discovered within the sealed court records part of the PPHM vs CSM lawsuit and these discoveries also may help further give clarification on the valuation of the Intellectual Property that certainly has not reflected in the current stock price. There has been an unusual large, continuous naked shorting of the stock that would allow some Big Pharma to place incorrect asset valuations. Evidence can be shown as the market cap leading up to the Abbot deal back in 2012 where the stock increased to about $5.40. Taking into account the comparative market values from then till now, with increased knowedge of the Mechanism of Action of Bavituximab as it helps increase responders and decrease off target toxicities, the current market cap simply does not make it possible to use when negotiating with any Big Pharma and that must be corrected first, as many investors will agree with.
One final note: We all hope the transition to this new Board of Directors will be the key to unlocking the value of the PS Targeting pipeline that has been locked up for many years and I thank each and every one of you for looking beyond the surface and perception of simply a failed clinical trial vs a drug that has a clear mechanism of action and allows for a set of biomarkers to be discovered as with Precision For Medicine and Epiontis have discovered, in Peregrines collaborations with each of them and there is daily data emerging that will hopefully make an impact on negotiations like none of you have seen before.
Thank You,
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01/04/18 1:50 PM
01/04/18 3:54 PM
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