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PDB, your call outs about lab interpretation confirmation don't make sense for what PPHM is addressing in Australia. Recall that IST refers to Investigator Sponsored Trial (performed by parties other than PPHM) and that Bavi performance has already been demonstrated in multiple HUMAN trials. Thus, you need not be concerned about possible synergies being determined in booths in Australia. When PPHM is in Australia, the attendees of this world lung cancer conference should be carrying the expertise to decide whether they like what PPHM has to share or not, based on the merits.
You might consider reading through the PPHM IHUB IBOX information if you want to become more familiar with the ISTs and human trial details that might come up during PPHM discussion in Australia.
Best wishes and IMO.
KT
Geo, agreed. If you consider yielding to a subpar Pharma deal as one book end and PPHM going it alone as the other, we can observe PPHM management trying to straddle between the two, bringing along the best overall outcome. Yet, if PPHM has to migrate to a bookend, the only one that enables PPHM control for addressing their interests as a company going forward is the go it alone strategy. It is in the hands of Pharma in negotiations whether or not we can determine whether the Pharma partnering is even a realistic outcome for PPHM, considering how, with hardship, the go it alone approach at least would plod its way along to completion of the Phase 3 Bavi trial. A subpar Pharma deal might just serve as the conduit for the Pharma to table Bavi after they are able to exercise their own management control. Why? Bavi development would displace multiple billions in annual revenues to Pharma, establishing a huge opportunity cost for a Pharma enjoying those sales to take measures that shift to a Bavi family future.
The suspicious activity surrounding the PPHM trials was able to be overcome primarily for two reasons: 1. PPHM staff caught the miscoding at CSM after data was unblinded and 2. Bavi was performing so well relative to previous trial results and the recovered trial data, combined control arm that the FDA saw cause to grant PPHM the Bavi Phase 3 trial design approval last June.
"Thar be Dragons", LOL!
Best wishes and IMO.
KT
Geo, how can someone look at all the uncertainty before us and determine resolutely that PPHM is going it alone for the Phase 3 Bavi NSCLC trial? PPHM is seeking a partner by year end and says if not successful, they plan on starting the Phase 3 trial without a partner. When assessing whether the partner hunt becomes an "all or nothing" proposition for PPHM, I look at whether the go it alone trial start is a viable option or if PPHM will be compelled to put Bavi development on hold until a partner steps forward offering fair terms reflecting share holder value being created through the development of the PPHM technology. My conclusion is that going it alone is not the preferred PPHM option for the Phase 3 trial, but PPHM can pursue going it alone as a viable option in lieu of accepting a sub-par partnering deal. Likewise, PPHM appears to be experiencing "isolation" from supportive resources making a go it alone decision more viable. Yet, if pharma plays "hard ball" in partnering negotiations so long that PPHM is compelled to embrace the downside of doing a go it alone trial start, the value to PPHM brought to a deal by a late entering partner diminishes the closer PPHM phase 3 trial data collection gets to being ripe for reporting to the FDA for that interim look.
Through their PRs, PPHM has let Pharma that might be interested in partnering with PPHM know that the cross over point for intercepting PPHM technology rights through a deal gets crossed at by the end of the year. Maybe PPHM has more time to yield for negotiations of a deal, but we have seen that Pharma competitors are bringing forward their own products for development. If PPHM management were to delay the trial start for much past January 1, the "sweet spot" for deal making AND start of the trial will have been breached, increasing the downside for PPHM investors. PPHM MUST keep a go it alone trial start option open or the only real driver that might bring realization of share holder value to long investors will be in the hands of a competing pharma bid process. Ultimately, those Pharma that are turning billions of revenue now for their standard of care treatments may still look at their opportunity cost tradeoffs as justifying leading PPHM along in negotiations with no real intent of ever signing into a deal.
PPHM is approaching an end game for negotiations, it seems, and investment in PPHM remains a very high risk endeavor.
Best wishes and IMO.
KT
jimsgtx, your call out with the language from the PPHM and CSM lawsuit serves to emphasize the "negligence" argument as explaining what transpired in 2012. Yet in a practical sense, the negligence argument just acknowledges how PPHM has to step away from the CSM internal dynamics of the intent behind what may or may not have occurred within CSM's "walls" as CSM exercised the duties of their agreement with PPHM to provide double blinded study services. PPHM is asserting that their discovery around September 20, 2012 was that analysis of patient data contradicted the labeling of what treatment was administered to the patient.
At the time the post-September 24, 2012 investigation was underway, posters heard clarification from PPHM that proper authorities had been informed and PPHM was deferring to their handling of query about the cause for the miscoding at CSM. For sake of the lawsuit, PPHM as plaintiff is asserting that CSM did not perform their contracted double blinded with placebo trial services in accordance with professional practices and contract language and is seeking compensation for damages as will be determined before the Court. Thus, the negligence claim does not carry over to precluding any charges that might be determined appropriate after investigation by legal authorities is complete.
Best wishes and IMO.
KT
Carboat, what will be the reaction of the market if PPHM proceeds with going it alone? My guess is that it all depends on the peripheral measures PPHM has or has not put in place, addressing how the funding will work, time lines and such. As I noted earlier, I don't expect a resolute outcome from the "go it alone" option to be in play until the February 2014 time frame. I would anticipate that, if a Pharma is to partner, they will have announced by then. The closer PPHM has gotten to bringing in Phase 3 trial data on their own, the less value a Pharma partner brings to PPHM.
Why bother with a partner if partner negotiations already pushed PPHM into taking the "down side hit" of going it alone as a consequence of hard ball, partnering negotiations? After all, there will not be much downside left if enrollment has proceeded to the point that enough data is "in the incubator" for PPHM to bring to the FDA for an interim review. If the Phase 3 interim review is not showing promise for Bavi to share with the FDA, that is where I see PPHM has serious problems that threaten its viability. That dynamic wouldn't likely play out to near the end of 2014, early 2015.
Best wishes and IMO.
KT
Carboat, are you projecting that PPHM would be a candidate for seeing its pps increase four fold to six fold above the current pps upon announcement of a Pharma partner for the Phase 3 Bavi NSCLC trial start? That would be a lot of pps movement for a "by the end of the year" PPHM business plan deliverable being achieved.
Is the market potential of THLD comparable to the broad platform anti-PS proprietary technology rights held by PPHM? If not, perhaps PPHM would enjoy a further multiplier reflecting the market potential difference?
Best wishes and IMO.
KT
Bio, profoundly stated.
As I recall, PPHM established their poison pill in conjunction with when Dr. Thorpe's team identified the role of PS and achieved segregation of a MAB that targeted it with initial intent to deliver a payload treatment attached, only to discover that the act of attachment to PS would induce an immune response. How long has PP had the poison pill? That would be about the start for Bavituximab (Tarvacin) of that drug development timeline. Twelve years is average, but it looks hopeful that Bavi will achieve approval quicker.
Best wishes and IMO.
KT
Bungler, interesting nuance you called out. It would seem my earlier point about the proxy vote before shareholders regarding authorizing more shares for employee incentives makes this suit moot. When a majority of share holders affirm their will, a lawsuit doesn't have much to stand on regarding critiquing how the board facilitates employee incentives.
Another point is that the suit is rooted from an existing share holder base. Wouldn't that suggest that a short interest would be unlikely to be behind the suit? If it were a short interest, partnering Pharma candidate or hedge fund with interests contrary to long investors' best realization of share holder value, the perpetrating party would be taking high risk of countersuits for high $$$ damages, it would seem. Those giving favor to this latest suit may be tipping their hands as to their underlying interests or perhaps, just exhibiting how vulnerable long share holders can be for making counterproductive decisions during periods of long PPHM news lapses.
Best wishes and IMO,
KT
Md1225, brother-in-law insights aside (LOL!), long shareholders need to keep the events surrounding March 2012 trial results (control arm that outperformed history of previous NSCLC trial treatment arms) and the September 24, 2012 events (clear evidence of dose switching at the double-blinded study CRO) consistently in their reference base as judgement calls are made about the PPHM board's performance. I don't agree that PPHM having "the Holy Grail" suffices as cause to open pathways to FDA approvals. There are too many of those currently commercial treatments earning billions annually prime to be bumped aside if a Pharma can latch on to the Bavi, anti-PS family to couple with their latest focus on down stream beta body immunotherapies. Another Pharma's opportunity cost needs to be acknowledged as being as much a factor in PPHM negotiations as their prospective benefits from acquiring PPHM tech rights. If the end game suggests that a current treatment earning billions will become a dead end towards worthless marketability with Bavi in approved status, that Pharma has a strong incentive to invest resources to impede PPHM. Of course, you have cited such things yourself in earlier posts.
A question to keep in mind is, would a PPHM communication arm a party with adversarial interests against PPHM long share holders and is PPHM in a SEC disclosure situation that requires the release of the information? If the answer to part 1 is yes and part 2 is no, the PPHM BOD is doing right by share holders to be closed about information sharing.
I figure PPHM needs through February 2014 to have sufficient time to play this out in order for there to be adequate information to make the critique against the PPHM BOD that many appear ready to make now. I also recognize that a go it alone PPHM option becomes much more a threat to Pharma if PPHM goes into February 2014 with a pps in the $3 to $5 range, better enabling the ATM funding mechanism able to bring in the $60 million guesstimated as needed for the Phase 3 trial. It has been clear that the closing pps has become an issue of importance to at least some, since records exhibit trades get tucked in around the closing second of trading. I have also observed that a party(s) is using dump sales of shares for trading during the day tallying around 150,000 shares but running as high as 300,000 shares to step down the pps trading range at opportune times. There is no good reason why a party would force a sale of shares in a manner that drops the pps if a share holder were seeking to get a return on their holdings of PPHM common stock.
Best wishes and IMO.
KT
Volgoat, this CA suit is a curious development, considering that shareholders have the proxy vote before them to approve employee incentive options. The previous CA related to September 24, 2012 is set to be tossed and this CA comes forward to keep a legal issue on the horizon while PPHM is likely negotiating with Pharma. Since a shareholder approval vote makes the current CA moot, approved or not (hard to class action an argument after a majority of share holders have asserted their preference on a proxy vote). Consequently, I am looking at this latest CA development as a very bullish indicator for PPHM prospects. Why? Some party(s) is seeing the need to raise obstructing issues in tandem with the period during which PPHM has formally announced to share holders their intention to partner or go it alone for that FDA approved, Bavi Phase 3 trial, by year end.
Best wishes and IMO.
KT
4OurRetirement, glad you asked your question because it led me to learning something I didn't know. Based on follow up posts, it sounds like a private company may manage its own stock for a limited number of share holders (<500?) but limited liquidity would make it untenable for these private shares to be used in lieu of cash for a PPHM buyout. I am not sure of the significance of the point made about buying a majority of PPHM shares can substitute for an outright buyout of the company, considering how SEC disclosure and the poison pill would compel a party seeking to establish majority share holder status to reconcile their acquisition of shares with the markets, at least when closing in on the "greater than 15%" portion of their majority status.
Regardless, we still need to look to next week for external dates to drive PPHM to news, if there is news to be shared, relevant for the ASM and October options expiration timing.
Best wishes and IMO.
KT
4OurRetirement, that was an easy question to answer if I understand what you are asking. A private company doesn't have stock to exchange in lieu of cash if they are seeking a PPHM buyout. If they had publicly traded stock, they wouldn't be a private company and vice versa.
Best wishes and IMO.
KT
Ex, Loof is the only poster who can offer prizes that would draw out the latent Bavi-naming talent in us. Them varmint squirrels and libations and all.
I recall the makers of Tarceva brought suit against PPHM after they said someone introducing a PPHM speaker presenting about Tarvacin at a conference stumbled the intro and first said Tarceva before correcting themselves. And to think, some posters were suggesting that Pharma hadn't even heard of PPHM, LOL!
Best wishes and IMO,
KT
EBS, there was that Seeking Alpha write up Chris wrote (Billion dollar deal Part 2) about there being an Abbott subsidiary (Abbvie) close to a partnering deal with PPHM before the September 2012 news about the trial product miscoding at CSM. Identification of PPHM's partner prospect was said to have sourced from the Amended Complaint filed in the Class Action suit against PPHM that some are presuming will be dismissed in mid-November.
I agree that the SA news ought not have brought about a 5+ million volume trading day (a million shares would be high volume compared to before and after) because the information in the SA article should already have been known to those who post on this board, but for the name of the potential September 2012 partner. If one figures that there was four and a half million "extra" volume traded, that amounts to about 3% of PPHM outstanding shares or about a fourth of reported short interest shares changing hands in one day. Does naming last year's potential PPHM partner give cause for "panic" trading on 10/2? To me at least, it really didn't matter but was nice to know. Yet, absent going back to the Court documents from the Class Action suit, the prospective partner naming roots into message board banter until the SA article elevated it to "rumor" status, LOL!
Best wishes and IMO.
KT
swg_tdr, thanks for your recent note. I tracked back to an earlier post I shared that addressed some of the critiques PPHM had been facing over the period leading into the June 2013 FDA approval of a Bavi Phase 3 trial announcement. The post is the one I am responding to now.
Regarding a division of Abbott being a prospective PPHM partner last year (per the Class Action suit amended complaint), I don't know if that year old partnering dynamic can be expected to carry over to who PPHM may be in negotiations with for partnering now. A lot can change in a year. I had been thinking that a partner prospect from September 2012 ought to have been ready to come back with all the more enthusiasm after PPHM finished their investigation of the miscoding of trial product that occurred at the CRO contracted to provide double blinding with placebo trial protocol services.
Maybe Abbott or an affiliate still carries interest in PPHM? Perhaps, a pharma recently mentioned on this board is showing interest? As long as the party is willing to pay a fair price, that properly reflects the shareholder value that PPHM technology brings forward, my only other concern would be that the partner has the good intentions of actually letting the Bavi tech advance to approval, rather than tabling the tech for purposes of advancing their own marketing interests. For now, we shall see if the October 28 Australia conference brings the good PPHM news that some had speculated is in the works.
The PPHM pps has an interesting dynamic going into the Annual Shareholder Meeting on October 17. A couple million October 19 call options are dangling out there which could come "in the money" if it becomes clear PPHM is delivering on their business plan and the pps moves above $2. Yet, October 28 is the timing of the Australian lung cancer conference. Will $2+ October call options expire worthless because PPHM news is perceived as imminent but not delivered in a way to move the pps? I hope not, but then, this is PPHM after all.... LOL!
My expectations for PPHM are still out in the February 2014 time frame, by which that end of year business plan for contracting with a partner will stand out black and white as to whether PPHM is going to meet this important milestone or step towards going it alone with the Phase 3 Bavi trial start.
Best wishes and IMO.
KT
Carboat, I follow PPHM news carefully and have never seen it reported by PPHM that there were errors with dosing or there has been a botched trial. If you are referring to the June FDA approval of the PPHM, Bavi Phase 3 trial design, that news contradicts your recollection of events. Have you seen news of the PPHM litigation with their CRO, CSM that gives substance to your statements? I have seen no such news, although I have seen posts that indicated with whom PPHM was in negotiations for partnering going into September 2012. That information was drawn from the amended complaint from the Class Action suit that was brought against PPHM after PPHM reported how they discovered clear evidence of dose switching while preparing Phase 2 trial data for rheir meeting with the FDA. PPHM wrote about the miscoding of trial product at the CRO, as reported premarket on September 24, 2012. Does that jibe with your recollections?
I am glad PPHM was successful in achieving FDA approval of the Bavi Phase 3 trial design, with an expansion of the double blinded with placebo trial design, 120 patients targeted for the Phase 2 NSCLC to 600 patients for the Phase 3 trial design, aren't you?
Best wishes and IMO.
KT
Carboat, the Phase 2 NSCLC trial censors issue was addressed in great detail by posters on this board when it was timely about eighteen months back. A few, like Mojojojo and I, also delved into the KM plots and I had even posted a yellow sticky that included a detailed recreation of each patient's status. I agree with Mojojojo that if you still have interest in the trial censored patient speculation that you can likely find it fruitful to go back in the posting record for review or you might do your own research.
I see patient censors as a red herring issue at this timing, since the FDA chose to grant PPHM approval of the Bavi Phase 3 trial design in June while the FDA was giving consideration to all such data that PPHM had brought before the FDA for review. The Bavi Phase 2 double blinded with placebo trial design has been described as the FDA's "gold standard" and is the design basis for the FDA approved Bavi Phase 3 trial design. The Phase 3 trial design is to enroll 600 while the Phase 2 involved enrollment of 120.
PPHM's decision to combine the low dose Bavi and placebo trial arms to compare with the 3 mg/kg Bavi arm was an expedient move after that miscoding of 1 mg/kg Bavi and placebo patient doses at the FDA approved CRO facilitating the blinding process was identified through investigation. Recall PPHM had discovered the clear evidence of dose switching announced on September 24 of last year while PPHM was preparing the blinded study data in preparation for the end of Phase 2 meeting with the FDA. Board posters also delved into that issue in great detail around that timing, when it was recognized by PPHM that combining the low dose Bavi arm with placebo delivered a very conservative comparator with the 3 mg/kg Bavi arm for FDA review. Despite the evidence of dose switching, the 1 mg/kg Bavi arm had been showing better performance than placebo for MOS, so combining that data with placebo results gave the 3 mg/kg Bavi arm a tougher comparator.
The bottom line is that, if you still see the need to catch up with PPHM history, the posts are still accessible on IHub for review, allowing you a head start while you revisit these old issues.
Best wishes and IMO.
KT
CB, Court proceedings don't establish "truth" that way. Bungler's post was calling out how the series of statements of fact made by the Plaintiff, even when uncontested, did not support a finding of harm or wrong doing as being claimed by the Plaintiff. The Judge's decision to accept PPHM's petition for dismissal is the reinforcing point. Now the Plaintiff is bringing forward additional claims in an amended complaint that the Judge will need to rule on. We shall need to wait for resolution, but the earlier dismissal action indicates directionally where the case is likely to go.
February 2014 is now just a bit over four months away, but is still plenty of time for PPHM to announce a partner or their decision to start the Phase 3 Bavi trial on their own.
I didn't catch up with all the posts about the audio tape from the PPHM conference booth, but I find the reference to 150 sites being targeted for recruitment to be very interesting. PPHM had used over fifty sites for their Phase 2 Bavi NSCLC trial and had mentioned how over 100 sites were targeted for the Phase 3 trial. Now we hear from a "back channel" that patient recruitment will be from a targeted 150 sites. It looks like PPHM expects to be getting some trial, patient recruitment help.
Best wishes and IMO.
KT
I took a second look at that "spin job" write up in the September 10 "The Street" that Adam Feuerstein wrote that was so critical of PPHM and offer some observations. If you haven't read the article, AF quotes PPHM management statements from the quarterly investment call and displays four financial charts while AF says they call out PPHM management "spin" about results. I even looked it over a third time to see what I might be missing, but I am left concluding that it is AF who is inserting the spin here. I am curious if others have looked at "The Street" article and came to similar conclusions.
What am I seeing that "is spinning"? Consider the four charts posted by "The Street" and weigh that with what those following PPHM developments might know by reading the Q reports.
AF's first chart shows the PPHM pps over the last quarter. Those of us following PPHM have seen those Bollinger Bands getting tighter since July 4 while pps has been hanging around $1.40 +/- about eight cents for a long time... Over two months. AF quotes PPHM management referring to excitement building up from the researchers who have been seeing the Bavi and other PPHM tech results and AF writes by that The Street, range-bound pps chart, "Where is the excitement?". I looked thoroughly through The Street article and couldn't find that Bavi trial KM Plot of Median Overall Survival that PPHM had brought before the FDA when the FDA granted PPHM approval of a Bavituximab with Docetaxel NSCLC Phase 3 trial design. You know, the one tht has the "tail" that separates the Bavi plus Docetaxel arm from the control arm that we have heard PPHM say has researchers excited because it is indicative of an immune response against the cancer.
Yep, there is spin called out in that The Street article. Those scientists and key opinion leaders in the field of immunology that Steve King said have been exhibiting some excitement about Bavi would be looking at that PPHM pps plot rather than those PPHM technology, trial results, right? Well, maybe if those researchers engage in insider trading, I suppose, LOL! Oops. Scientific charts. Financial charts. Is something spinning?
Should I bother going further? Who reads my long posts anyway... ? Well, as long as I have gone this far, let's look at the next AF chart for signs of spin.
AF's second chart plots the PPHM pps trend alongside the national biomass index, which shows the NBI has trended up while PPHM pps has trended down. The Street article notes, "Mind the Valuation Gap". Can this be? I mean does The Street expect that a small biotech like PPHM that is seeking a partner with deep pockets to help fund PPHM's two FDA approved Phase 3 trials should be outperforming the national biotech index during what is being referred to as a bull market? Keep in mind that PPHM has been trimming back quarterly losses, in part, due to Avid sales improving, but that NBI includes Pharma with commercially approved products bringing them $ Billions in earnings.
Maybe AF meant to suggest that PPHM might see the pps rise to outperform the NBI if that significant interest in the science community translates to a Pharma signing on to a partnering agreement that lets the investment community know that PPHM will have ample funding to move PPHM's proprietary tech to market? Otherwise, The Street ought to carry enough expertise to at least offer some conjecture that the market won't value PPHM seeking partnering for a Phase 3 trial until one gets announced? Maybe the spin AF is flagging is that one can't look to the pps for signs of a partnering deal unless there is a breach in confidentiality agreements signed by "interested" Pharma? Something that involves the delivery of inside information to some in the investment community? Yikes, this post is getting long and there are two more charts spinning in The Street!
That third chart shows the Avid recent four quarterly sales shifting up and down, with the statement "does this look like solid sales growth to you?". There is a little note that AF made that the PPHM FY 2013 Avid revenue totaled $21.3 million. The article carries the earnings statement made by Paul Lytle, who noted how commitments for Avid production already in place for PPHM FY 2014 are estimated to bring revenue of $18 to $22 million. However, The Street indicates that statement is PPHM disclosing they are "guiding down" for the 2014 Fiscal Year. Is that how the experts at The Street make revenue growth assessments and obtain management guidance statements? That is, they plot four quarters of fluctuating sales to posite that the annual totals for the last several years don't exhibit growth? Four quarters tally into one year. Hmm. Maybe The Street doesn't know that orders typically vary quarter to quarter (not likely)? Or that there might be more orders delivered to Avid beyond those already posted just three months into their Fiscal Year? Ooh, my head is starting to see a lot of spinning..... Maybe AF presumes Avid production is fully subcribed so Avid cant accept any more orders (not likely)? But then, if PPHM claims revenue projected from orders they don't have, analysts might object that...but.... spin, spin, spin.
Now for Chart 4. The Street chart shows outstanding shares increased by 40 million and can be expected to increase by more to cover the cost of what might be $60 million for the Phase 3 trial. Whew! This projection of increased outstanding shares if no partner brings cash to the table actually makes sense! AF even gets the quotes from PPHM in line with Paul Lytle amd Steve King saying PPHM is seeking a partner by year end but is prepared to start the trial without a partner "if necessary". So, The Street "gets it" that PPHM benefits from a partner that provides trial funding so PPHM doesn't need to scrounge for other funding like more ATM placements.
But then The Street neglects to mention the chilling effect that September 24 CRO miscoding of trial product had on PPHM financials. That was when the PPHM pps had climbed up to $5.50 in anticipation by some of a partnering announcement and dropped over 80 percent with just five minutes of pre market trading. The Street doesnt mention the CRO miscoding investigation that led to data recovery and FDA Phase 3 trial design approval. There is nothing about how PPHM had to scramble to replace the $32 million two tranche line of bank financing that had to be returned, post September 24 The Street doesn't even mention PPHM is debt free, essentially warrants free, still carries full technology rights for their FDA approved Phase 3 trial ready products, removal of that going concern clause nor PPHM's built up a $41 cash reserve.
Does it count as spin when an article published in "The Street" selectively withholds information available and relevant for the subject and conclusions, the absence of which enables the reader to take away a message contrary to facts publicly available from credible sources? Probably not, considering how deadline driven, hastily researched article writing is the mainstay of journalism. But then, the subject of this particular The Street article is, after all, claiming to call out spin by others. Now my head is spinning.
Best wishes and IMO.
KT
CP and CB, I am just calling out what portion of Avid sales appear to be available to assist with PPHM operating expenses. To CP's point, there is no profit involved with PPHM that subjects PPHM to Federal corporate taxes because the financials from Avid are joined with PPHM's, who is still making net outlays for studies and such (no profit). To CB's point, yes, the cost of goods sold would be deducted from sales to determine the gross margin. To my point, the 50% margin math should be looked at as the "markup" beyond the cost of goods sold that PPHM was able to carry with Avid sales. This increased from about 25% from a few quarters back to 50% this last quarter (my observation). Avid's reported improvements in batch yield (at a recent conference) is what I am assuming as the reason, but that is my guess.
CP, to clarify the rough math, again, PPHM is showing no profit that is taxable so we can ignore tax considerations. PPHM is estimating Avid sales for their 2014 Fiscal year (ends April 30, 2014) at around $20 million, +/- about 10%. IF PPHM carries an Avid gross margin at about the same ratio as recently reported (about half of cost of goods sold or 50%, sales of $21 million might contribute $7 million to defray other PPHM costs. 7 is a 50% markup of 14.
Regardless of what other costs are being covered by ATM funding, the increasing Avid sales are reducing how much ATM funding is needed.
Carboat, I don't want to delve into definitions in accounting, since my point is that Avid sales, even if steady, are contributing more to help the bottom line than was previously posted in PPHM financial statements.
Best wishes and in the opinion of a non-accountant, LOL!
KT
CP, The math with a 50% Avid gross margin translates to a third of sales helping the PPHM bottom line. So if Avid has $21 million in sales for the year, about $7 million is contributed to PPHM needs. This is additional to the value for Avid production of PPHM trial products. The margin improved from last year, due to ? But Avid has cited productivity improvements in their recent presentation. Productivity improvements can explain the profitability improvement.
Best wishes and IMO.
KT.
Carboat, it is not clear as to what you are questioning about PPHM in your exchange with Geo, but you can go to the Q report and see that Avid sales relative to Avid production costs carry a 50% gross margin. Your reference about use of ATM funds to provide operational funding to Avid isn't applicable here because Avid is a fully owned subsidiary of PPHM and a loan taken out against Avid carries through to an obligation by PPHM.
Whatever the case may be, the absence of financing that carries collateral against the assets of PPHM the company is a positive if conditions for a loan include provisos similar to what was detailed in the two tranche loan instrument that PPHM had in place about a year ago. There are no encumbrances against the PPHM intellectual property or constraints on PPHM alternate forms of capitalization.
I wish you well with your PPHM investment.
All IMO, of course.
KT
CP, I offer an add on to your point as to why ES "got there" for receiving compensation from PPHM. You wrote, because he had cash. Having been invested in TCLN/PPHM around the timing of ES's entry, I note ES also was willing to apply that cash into PPHM investment that helped keep the company from failing, in a manner that did not crush the pps with alternatives that could set up death spiral financing.
I recall how PPHM hovered at a presplit pps of around a buck with excursions below a buck that lasted long enough to place NASDAQ delisting into play on a too frequent basis. ES came forward with critical multi-million cash investment that kept the TCLN collective heads above water while ES assumed his position on the TCLN/PPHM board of directors. Later, ES and PL helped PPHM transition away from private financing that assigned warrant rights to each share sold, to the more share holder friendly ATM process for raising funds. The result was that PPHM is now debt free and essentially warrants free, carrying unencumbered technology rights at timing when PPHM is offering both Bavi and Cotara for partnering with FDA Phase 3 trial design approvals in hand.
Of course, a long term consequence of PPHM moving Bavi and Cotara through that expensive trials path without a partner was also that PPHM incurred the 1:5 reverse split and issuance of millions of new shares, significantly increasing the count of outstanding shares while PPHM raised $100s of millions to support trials and operations. Some long investors may have addressed PPHM's new share issues with an investment strategy that cost averaged their way along to keep their share balance ownership percentage at or above the balance when ES came on board. For example, my current post split equivalent share count is about 600 times that of my first TCLN investment about a dozen years ago, increasing the size of the "piece of the PPHM pie" that I own over time. Some may have just held their earlier investment from whatever timing and pps over the last dozen years. Regardless, at least in my case, I had the opportunity to sell my holdings for a nice cost averaged, overall profit in the period leading into September 21, 2012, as I presume would have been the case for many long investors that held through that period. Going into September 24, I had chosen to hold my shares.
Consider then the news of the Phase 2 Bavi trial CRO trial product miscoding discovery that was announced premarket on September 24, 2012 that triggered the premarket pps drop of over 80% within five minutes of premarket trading. On September 24, I also expect that most long investors saw the cost averaged value of their investment go "south" of break even. Yet all but a few chose to not sign on as plaintiff for any of the five post September 24 class action suits. As of September 17, 2013, only one plaintiff remains engaged with an amended complaint that should be addressed through the legal process by the end of the year.
I consider the role that ES played through all this as having been crucial for preserving my investment value and am optimistic that PPHM will be delivering trial results, partnering or progress in the Phase 3 Bavi NSCLC trial that can deliver a greater return than what I could have experienced if I sold about a year ago. It is my anticipation of the set up of dynamics PPHM currently has put in play that was my reason for initially investing and sustaining investment in PPHM over the last dozen years. I am still looking at February 2014 as being representative of how long I may need to wait for PPHM to have worked through the Bavi Phase 3 trial start dynamics, but would be pleasantly surprised to see a faster pace.
If February 2014 comes without an appreciable improvement in PPHM's standing, I will cross that bridge if circumstances place it in my path. If the value of my PPHM shares moves toward becoming worthless after February, I will be surprised and disappointed, but figure in how people I know and care about have been suffering from cancer and viral infections and how the good work of research teams like those led by Doctors Patel, Epstein, Thorpe and now Bakken have brought what I view as significant progress towards developing a cure. Altruism and investing can be viewed by professionals as having no place in the investment world, but when it comes to being a retail investor, I have freedom to make choices considering how my investments might improve the common good while prospectively returning me a profit commensurate with the investment risk involved. There is a bit of irony that PPHM is now positioned to participate in much of the same conference and research news sharing path that they were on a year ago, before the CRO miscoding problem was discovered and reported.
Thanks for sharing your insights!
Best wishes and IMO.
KT
Jake, the issue gets somewhat circular, doesn't it? The lawsuit can preclude closure of an agreement with a Pharma partner, which along with the Phase 3 trial design approval by the FDA, were the two deliverables in the works around September 24, 2012. No lawsuit closure. No partnering deal. No start of a competitive drive to a Pharma who might stand to lose billions in annual revenue when Bavi goes commercial. This doesn't need to be a "tit for tat" unless a Pharma partner insists on it. What Pharma would want to partner with PPHM if they thought one of their competitors could be behind the scenes encumbering their business plan viability by pulling the strings on a class action suit?
Whatever the case, it isn't fair to entangle you with what another party is doing in a shareholder lawsuit. The proper action would be for the judge to resolve the issues before him with a decision. Although, you did entangle yourself with your comment..... Why didn't you join those listed with the Class Action Suit when the law firms were advertising for parties to come forward about a year ago?
Best wishes and IMO.
KT
Jake, really??! Don't you consider the PPHM management investigation that led to recovery of the Phase 2 NSCLC study results that in turn led to an FDA Phase 3 Bavi trial design approval to rate as a management effort to make things right? Wow!
Since this is offered as a Class Action Suit brought on behalf of all share holders, I find it remarkable that, so far, you are the only other party who has claimed they are a share holder with standing on September 24, besides the Plaintiff, Mr. Anderson, that I have seen express any support for this lawsuit moving forward.
Do you acknowledge that PPHM management acted to achieve the FDA approval of the Bavi Phase 3 trial? Do you also acknowledge that a share holder lawsuit can be a valid encumbrance for PPHM entering into a partnering agreement? If not, I would appreciate it if you would explain why not. If so, why would you support an amended complaint that may extend the duration of an encumbrance on PPHM closing a partnering agreement (presuming such an agreement is in the works, as is being sought by PPHM management)?
I am watching to see if the judge throws out the amended complaint so that PPHM can continue their business plan implementation unencumbered going forward. We shall see. Ironically, if there is mischief in play with this class action suit, the encumbrance could be getting guided by a third party Pharma not wanting to see PPHM proceed with a partnering deal.
Best wishes and IMO.
KT
CP, the Avid productivity improvement being presented can explain why the gross margins from mabufacturing increased to about 50% in the last quarterly report. I recall it had been running about 25%.
Best wishes and IMO.
KT
Volgoat, Talk about irony! The class action suit that cast a shadow of doom and gloom last September after the PPHM pps dropped from $5.50 to below a buck during premarket trading on September 24, 2012 is still seen as shadow casting its doomy influence approaching the one year anniversary of that September 24, premarket pps drop.
Do you think an action taken by a few parties who agreed to be "lead Plaintiff" can really be the cause of a pps conundrum that has contributed to PPHM being tight on funds all the way past the January 2013 post investigation announced recovery of the Phase 2 trial results and the June 2013 announced FDA Phase 3 Bavi trial design approval in June through now? It brings to question, what productive purpose could have been intended with the class action suits? Was it to parse out "leftovers" value to investors? Or perhaps, crushing PPHM the company after the miscoding at CSM was reported was reported. According to a couple reporters at the time, the miscoding at CSM was said to have pretty much closed the door on Bavituximab, PPHM's lead product, and with it, PPHM's anti-PS treatment platform. But then when one considers how it likely took several parties by surprise when the PPHM investigation recovered the value of that Phase 2b study and achieved FDA Phase 3 trial design approval anyway, it is not that surprising that a mechanism would have been put in play that would squeeze any remaining financial life out of the company before a redo of the Bavi trial could be achieved. It sort of puts an exclamation mark on how brazen some party's attempt may have been to set back PPHM, if one ascribes to conspiracy theories, doesn't it?
It also has me thinking about whether PPHM management and employees deserve to get that requested allotment of shares for employee incentives that was put on the Proxy for the October annual shareholder meeting. That was quite a gauntlet PPHM ran over the last year and my investment is still carrying potential for the high return value I was seeking before that CRO miscoding and subsequent class action suits came into play. To clarify, the lead Plaintiffs recruited for the Class Action would not necessarily and likely don't have any connection with the behind the scenes maneuvering, but that was quite a one-two punch that PPHM has taken and still stayed on their feet.
Best wishes and IMO.
KT
Sunstar, your call out about how interim targets being set with multiple conditionals as being a reason for PPHM hesitancy about calling out terms for an early look make as good sense as any, I suppose. Another prospect (although it might be more far fetched) is that PPHM actually has a partner pending coming into agreement and that the pending pharma partner has indicated that once they are on board, they want to tune the trial to accommodate provisions that make sense for the partner's situation. I observe that the Docetaxel control arm is a product marketed by a single pharma that is available by generic. PPHM's understanding with the FDA may be that if a partner comes on board before the trial start, reasonable trial design adjustments can be made.
If your scenario is correct, it would suggest that PPHM will be positioned to turn early results to win an Advanced Approval while only expending a small portion of that $60 million and recruiting a fraction of patients. The balance of the Phase 3 trial patient enrollment would then be coming after Bavi is a commercially approved treatment or ??? Interesting, if that is how Advanced Approval works.
Best wishes and IMO.
KT
Bungler, good point and thanks for the FDA language regarding double blind with placebo protocol.
Expanding on your point, one might expect that statements that are made that reflect profound ignorance at timing when PPHM is engaged in litigation and seeking a Pharma partner are motivated by the preferred outcome of those drivers. If one asserts that PPHM should not be anticipating any financial settlement with CSM that might defray PPHM Phase 3, "go it alone" costs, the case for PPHM hardship is presented as more severe than if PPHM wins a settlement. In that sense, the statement really wasn't an expression of ignorance, was it, LOL!?
Best wishes and IMO.
KT
The PPHM fact sheet update that CJ referenced yesterday pretty much addresses the punch list of items I wanted to hear clarified during the conference call except for a direct statement justifying why PPHM needs more shares authorized for employee incentives. I also noted that I don't expect to see a resolute signal telling retail investors about whether PPHM is "going it alone" through a Phase 3 trial until around February 2014. So what are the financial implications if PPHM carries status quo into February?
For starters, the PPHM fact sheet indicates PPHM's burn rate is about $7 million per quarter. If we assign two quarters of burn rate to carry from today through mid-February, that suggests PPHM either needs to raise about $14 million through ATM placements (just under $3 million a month) or expect to see a draw down of their cash reserves from the current $41 million to about $27 million. Since PPHM has apparently adopted a business plan strategy to keep the going concern clause off their financial statement, retail investors might expect to see another 10 to 12 million shares of stock issued by PPHM through February 2014, perhaps more if PPHM decides to attempt a build up of funds to support their go it alone strategy to implement a $60 million, three year study.
So what about February 2014 on? By my figuring, retail investors ought to know whether PPHM was able to bring on a partner willing to pay fair value for PPHM technology access. IF a partner is announced, PPHM ought to be able to finish the Phase 3 Bavi trial without financial hardship and can anticipate the new partner would help fund additional trials to expand anti-PS family applications. PPHM market capitalization ought to be significantly enhanced, delivering value to all share holders.
If no partner has been announced, PPHM can be expected to muddle along with ATM placements if the share price supports doing that, working with their pool of an additional 150 million shares that can be issued to raise capital, on the outside edge, thus suggesting risk of a a prospective doubling of current outstanding shares in the process. In return, if Bavi and the PPHM anti-PS technology works as demonstrated through the Phase 3 NSCLC trial, PPHM investors should reasonably expect an FDA commercial approval for Bavi, creating a prospective multi-billion dollar revenue stream in a situation where PPHM has retained all rights for the financial benefits thus derived, sharing with the UTSW in accordance with technology rights agreements. PPHM share holder equity might be expected to be enhanced accordingly, likely more so than if PPHM partnered, but the issuance of new shares the ATM might have diluted the size of the slice of the PPHM "pie" held by an investor if they did not increase their holdings to offset the dilution. Ideally, shareholder equity enhancement through a successful Bavi commercialization enabled by the ATM funding more than offsets the impact of dilution.
Of course, if the PPHM Phase 3 2nd line NSCLC Bavi trial with Docetaxel doesn't show at least a two month improvement in Median Overall Survival using Bavi, PPHM will be needing to focus on other applications than Bavi anti-cancer, such as "next generation" drugs.
What investors who chose to take a short position in PPHM decide to do with that 16 to 17 million short interest through this uncertainty will be an interesting show, but Retail investors only get information that lags a couple weeks old behind what actually happened. That creates opportunity for misinformation and share price manipulation. Also, any institutional investor response reporting lags as much as six weeks to eighteen weeks behind what actually happened. In the interim period, I plan on just hunkering down through February 2014, watching for signs from PPHM that their business plan is still working out. A near term partnering deal announcement would be nice for making the wait less suspenseful, but if PPHM is going to need to go it alone to deliver fair share holder value, so be it. If most retail investors decide to hunker down to see if PPHM delivers a partner or not, we can anticipate a lot of clamoring by those who would financially benefit if PPHM retail investors decide to sell their shares.
Best wishes and IMO.
KT
Carboat, the "clear evidence of dose switching" has been also referred to as "miscoding" of trial products identified as having occurred at the CRO. Miscoding at CSM describes what happened, based on pre PPHM/FDA meeting investigation. The "clear evidence of dose switching" assigns judgment as to the intent of the party(s) who were involved with the miscoding of trial products discovered through investigation as having occurred at CSM. Either way, the miscoding of trial products occurred at the CRO who was contracted to provide the coding services for that double blind with placebo, "FDA gold standard" trial. The intent of the party(s) involved with the miscoding would be expected to be germane to how penalties and consequences to CSM play out.
We know from Court records summarized on this message board that the matter is in litigation brought by PPHM against CSM and the parties are going to trial after not reaching an agreeable resolution during arbitration. One might speculate that the intent of the party(s) involved with the CSM miscoding and lapses in CSM procedures that enabled the miscoding are a big part of what the lawsuit is about. If the suit gets settled, all PPHM investors may see is the terms of the settlement without there ever being a resolution of the intent of the CSM party(s) involved with the "miscoding of trial products" at CSM. Yet, if the suit goes to trial, the judge's decision will speak volumes about what happened.
I would expect CSM to settle if they can persuade PPHM to sign off without CSM needing to admit fault that enables the sort of more "open ended" financial claims that might be made against CSM if the miscoding was a result of an intentional act(s). In turn, an intentional act determination by a court decision opens up FDA, SEC and FBI entry into the resolution and gives cause for further investigation as to who ordered the intentional acts. I suspect CSM would want to avoid that outcome and will hold out against same, just as PPHM would want to see that determination made.
Let's not forget that photo from the CSM web page that was shared through a post on this board shows three CSM employees involved with the CSM process of applying coding labels to trial product. If CSM procedures applied that depicted triple custody protocol when implementing CRO contracted duties for this FDA approved, double blind with placebo trial design, it speaks volumes about whether a single oversight by a single CSM employee could have enabled the miscoding or whether errors by multiple CSM employees or an intentional act by one or more party(s) was involved.
Best wishes and IMO.
KT
Carboat, "Clear evidence of dose switching" having occurred at CSM based on post study analysis is enough detail to make your suggestion invalid, don't you think? We also know that PPHM achieved FDA approval for the Bavi Phase 3 trial design while the FDA gave consideration to the post investigation Phase 2 trial data. That adds an exclamation mark.
Best wishes and IMO,
KT
CP, thanks for your comments regarding form T records. Regarding the cost per patient in a Phase 3 trial, I note that PPHM hesitated on the call when they said that the cost per patient "typically" runs at $100,000. Since the Phase 3 trial is being facilitated using the same protocol as the NSCLC Phase 2b trial, it raises interest in what it cost PPHM on a per patient basis to do the Phase 2b trial. They are both double blinded with placebo, but the 2b trial involved 120 patients and the Phase 3 trial will involve 600 patients. Did it cost PPHM 120 X $100,000 = $12 million to do the Phase 2b trial facilitated across 50 recruitment sites world wide?
Maybe. A review of the 10Qs over the last two or three years would give a hint, but PPHM was doing seven trials simultaneously, coordinating with some Investigator Sponsored Trials. What cost gets allocated to what trial? I expect that the PPHM cost for running the Phase 3 trial will be less than $100,000 per patient, perhaps half that value.
Best wishes and IMO.
KT
Carboat, so are you saying that PPHM seeing their tech presented at the AACR written up in a peer reviewed Journal as announced today just gives cause for a bear raid? LOL! Such optimism....
Best wishes and IMO.
KT
CP, PPHM answered some of what was on my list of questions. We now know that PPHM restored their cash on hand to over $42 million as of September (6?) using the ATM shares sold at an average price of $1.43. During the investor call, PPHM clarified that they had $41.6 million at end of first quarter (July 31, 2013) up from $35.2 million at the end of FY 2013 (April 30).
It seems reasonable enough to me that PPHM is preserving their cash level as they engage ongoing partnering discussions, providing them with "much flexibility".
Another point I find interesting is the Sunrise trial design. In this Phase 3 trial, they keep administering Bavi until progression, not a fixed number of doses. Also, PPHM said over 100 sites world wide. During the Phase 2 trial, they enrolled over 50 sites world wide. PPHM also indicated that they are seeking to enroll and complete the Phase 3 trial in a two year period, expecting a third year for patient follow up. Treatment costs averaging $100,000 per patient were cited, but PPHM indicated the cost will be spread out over that three year period.
If there is an interim look with 50% to 60% patients eventing and the trial starts recruitment before year end, PPHM should have results by the end of 2015, if not sooner. It was also noted that PPHM was looking for a two month or better improvement in Median Overall Survival as an indicator of trial success. Not too much of a reach goal considering the Phase 2 trial results, even after the Phase 2 trial had the placebo and low dose Bavi combined into a revised control arm.
Best wishes and IMO.
KT
Corporalagarn, you drew a different interpretation from my post than what I was sending. No big deal. If those small readership reporters were communicating a message that was harmonious with the outlook of a hedge fund or a behind the scenes pharma, there would be a different significance placed on what the reporters were writing than if the reporters were just writing of their impressions after having done investigative reporting. I don't see signs of much of the latter as having occurred.
I am a little (but pleasantly) surprised to see the pps climbing above $1.50 today. February is a ways off.
Best wishes and IMO.
KT
CP, by February 2014, I am referring to whatever status is needed for PPHM to have achieved an "investor disclosure" status. Until which time something like a memorandum of understanding or some other firm commitment for negotiation into buyout or partnership is signed, PPHM will be just communicating "we are in talks". What else can be said if either party can walk from the negotiating table without any encumbrances?
If it takes a month to translate conceptual agreement achieved by a Pharma and PPHM into a legalese supported commitment and if PPHM is planning on starting a Bavi Phase 3 trial by the end of 2013, I yield a month to legalese prep and come up with February 2014 as a "foot dragging" Pharma deal timing for ripe disclosure. It can take longer than February 2014 if a Pharma had to be nudged by appearance of a competitor to enter into an agreement, even after PPHM announces a Bavi Phase 3 trial started without them (PPHM is going it alone) such that the Pharma needs to "catch up" to get back in their place in line for a deal.
I keep in mind that if PPHM announces they actually started the Bavi Phase 3 trial without having found a partner, that is like announcing to the Pharma world that the prime negotiation seat is now available for whomever wants to bring forward an offer that fairly represents the value of PPHM tech to both PPHM and the Pharma. As long as the anti-PS PPHM proprietary technology keeps performing and gets validation for effectiveness, PPHM holds its advantage. The way the science reinforcement is going for the anti-PS platform and Bavi, I stand by my earlier point that the longer a Pharma waits to make a deal, the less value a Pharma deal brings to PPHM and PPHM investors and the more a Pharma ought to be expected to offer.
My thinking is that Pharma was caught surprised in June 2013 when the FDA approved the NSCLC Phase 3 Bavi trial design after so much hype was made by a few reporters about how the CRO's dose switching during the Phase 2 trial left Bavi performance in question. January 2013 saw PPHM announce that the Phase 2 trial results had been recovered by combining the placebo and low dose Bavi arms to compare against the higher dose Bavi arm. That was the "hint" for Pharma that PPHM was regrouping after the September 2012 CRO miscoding setback. June 2013 was only three months back but found PPHM announcing FDA approval despite what had been referred to earlier as intentional, third party miscoding of Phase 2 trial arm products.
Nice! PPHM achieved a major development value deliverable touted as needing a partner without a partner. Now PPHM is positioned to deliver a Phase 3 trial implementation touted as needing a partner without a partner, if needed. What will cost a prospective PPHM Pharma partner more, loss of revenue from products Bavi and the PPHM anti-PS technology will displace or the cost to meet terms acceptable to PPHM and PPHM investors?
Best wishes and IMO.
KT
EBS, I forget the name of that movie addressing the Facebook story, but your parallels about My Space break down when mapping over to the PPHM situation. For starters, the technology you suggest as Bavi competition functions "downstream" in the chemistries in play, as was recently well explained by PPHM. The peer reviewed Journal paper announced today puts an exclamation point on what PPHM shared at the AACR. Also, the anti-PS technology is proprietary to PPHM, either directly or through licensing from UTSW, Dr. Thorpe. The driver for PPHM shareholder valuation hasn't really changed: either the anti-PS mechanism and PPHM's Bavituximab PS targeting technology works or it doesn't. Peer reviewed publications like that announced today affirm that the PPHM technology work.
Of course, caution about "to the moon" optimism about PPHM prospects is always in order, especially after that September 24, 2012 announcement that PPHM found clear evidence of miscoding at the CRO responsible for coding and distribution of the Bavi Phase 2 NSCLC, double blinded with placebo trial. Bavi ultimately outperformed that set back and achieved FDA approval of PPHM's Phase 3 NSCLC Bavi trial design, anyway.
What do I look forward to seeing from today's investor CC after the close?
1. Context from PPHM about how their PR today reaffirms that the Phase 3 Bavi trial will start by the end of 2013.
2. Information about outstanding shares, average sale price of ATM shares (if any) and an update on PPHM cash on hand (last update was $42.5 million). That is an indicator of what resources PPHM carries to support that "by end of 2013" Phase 3 trial start.
3. Updates on the PPHM trials, including those ISTs that ought to be delivering a status report.
4. Status of partnering discussions and PPHM timing for business plan developments, as can be shared.
5. PPHM justification for requesting more shares to deliver performance incentive options to PPHM management and employees.
6. Is Break Through Designation just message board hype or is PPHM in position for an Advanced Approval or BTD?
That mundane stuff adds up to an interesting bundle. I still see breaking through the call option threshold of $1.50 pps as being more meaningful than this sub $1.50 trading with low volume. I would also be pleasantly surprised if PPHM delivers a partner or buyout with closure much before February 2014.
Best wishes and IMO.
KT
Carboat, I disagree about this point you cited, as well: "But it would certainly be that the bp did not think given the current results it is worth what pphm is asking right."
Why? Just because a Pharma chooses not to buy something for resale doesn't mean that the underlying treatment doesn't carry the technology value or worth of what PPHM is asking. For example, the Pharma could be turning $6 billion a year in sales of product that would be displaced from the market by a successful Bavi and anti-PS platform, FDA approval and market commercialization. The Pharma may have determined that their withholding partnering support from PPHM (or perhaps their acting to thwart Bavi development) might add another year or two (or forever) to the time needed for PPHM to bring Bavi through a Phase 3 to FDA approval. In such a case, the Pharma may have decided that it is in their best interest to "make hay while the sun still shines" and leave Bavi on its own to get implanted into commercial use for "haymaking", if PPHM can pull that off despite the obstacles they throw in the way. After all, a Pharma might have cause to think they will get a reprieve if the Phase 3 trial fails to deliver resolute results after PPHM again finds that the control arm is remarkably outperforming control arms from all previous trials (LOL!). Bavi trials seem to have a track record of invigorating their control arms used for comparison to remarkable performance levels, don't you think?
Enough of this for a Friday. I hope all have a great weekend.
Best wishes and IMO.
KT
Carboat, a situation where those potential Pharma candidates get to look at what PPHM has under the shield of non-disclosure agreements but then decide to walk away, has always been a risk factor for PPHM investors. Yet, the reason for walking away matters, since they may or may not be indicative of problems with the tech. For example, the walk away from negotiations can simply reflect how Bavi developed into carrying too much value for a partner to afford at a price fair to PPHM investors after the FDA and PPHM pretty much caught the Pharma parties at the negotiating table by surprise with that pre-ASCO, NSCLC Bavi Phase 3 trial design approval.
Yes, I do think the FDA approval of the Bavi Phase 3 trial design announced in June caught Pharma by surprise. PPHM had been negotiating with Pharma about a year ago, when PPHM had announced that they signed on to a two tranche, $30 million bank financing for purposes of funding PPHM needs while they sought FDA, Bavi trial Phase 3 approval and tried to establish partnering to help with the FDA approval process and to subsequently help launch the study. That surprise is indicated in a few areas. First, there was the surprise September 24 2012 premarket announcement of the Fargo CRO miscoding of product during the Phase 2 Bavi NSCLC trial. That event was being postured as a "show stopper" for Bavi by investment blog writers like AF who were attending Pharma conferences at which Bavi performance was being presented. Additionally, there is the events where PPHM pps ran up from under a buck levels to $5.50 through September 21, 2012. Many posting on this board, including myself, were viewing this substantial pps run up as a signal that a Pharma deal was imminent. That lasted until the surprise when partnering deal hopes apparently collapsed, as the pps dropped over 80% during September 24 premarket trading.
Your point about how if a partner chooses to not come on board in the next five months, Bavi will not likely achieve a multi-billion commercial value is situational for the partner's business dynamics and is not necessarily reflective of PPHM anti-PS family prospective market value. If a Pharma decides PPHM grew up too fast for them to achieve that lucrative deal that places the reins for Bavi and anti-PS platform development into their hands at a cheap price, PPHM may well find that it is in their best interest and in the interest of their investors to continue moving the Bavi development bar along without Pharma partnering help.
I called out in my post to you yesterday how I think PPHM long investors need to be patient enough to wait until February 2014 before we can resolutely determine whether PPHM management delivered on their business plan for the Bavi Phase 3 trial start, partnered or not. I noted this morning how options trading appears to provide me with opportunity to position an investment around my guesstimated (and PPHM announced) PPHM management business plan delivery time frame. I attached below the NASDAQ call option table from this morning to serve as a baseline for my future reference about how well PPHM is doing regarding bringing share holder value through their Bavi Phase 3 trial start and partnering attempts through February 2014.
Best wishes and IMO.
KT
Option Chain for Peregrine Pharmaceuticals Inc. ( PPHM)
Calls Last Chg Bid Ask Vol Open Int Root Strike Puts Last Chg Bid Ask Vol Open Int
September 2013
Sep 21, 2013 0.90 1.00 0 PPHM 0.50 Sep 21, 2013 0.05 0
Sep 21, 2013 0.45 0.40 0.50 0 1 PPHM 1.00 Sep 21, 2013 0.05 0
Sep 21, 2013 0.09 0.03 0.05 0.10 50 1598 PPHM 1.50 Sep 21, 2013 0.17 0.10 0.15 0 219
Sep 21, 2013 0.05 0.05 0 20 PPHM 2.00 Sep 21, 2013 0.55 0.60 0
Sep 21, 2013 0.05 0 PPHM 2.50 Sep 21, 2013 1.00 1.10 0
Sep 21, 2013 0.05 0 PPHM 3.00 Sep 21, 2013 1.50 1.65 0
Sep 21, 2013 0.05 0 PPHM 4.00 Sep 21, 2013 2.50 2.60 0
Sep 21, 2013 0.05 0 PPHM 6.00 Sep 21, 2013 4.50 4.60 0
Sep 21, 2013 0 PPHM 7.00 Sep 21, 2013 0
Sep 21, 2013 0 PPHM 8.00 Sep 21, 2013 0
Sep 21, 2013 0 PPHM 9.00 Sep 21, 2013 0
October 2013
Oct 19, 2013 0.85 0.90 1.00 0 134 PPHM 0.50 Oct 19, 2013 0.05 0 0
Oct 19, 2013 0.45 0.45 0.50 0 430 PPHM 1.00 Oct 19, 2013 0.05 0.05 0 662
Oct 19, 2013 0.14 0.04 0.10 0.15 50 1854 PPHM 1.50 Oct 19, 2013 0.35 0.15 0.25 0 750
Oct 19, 2013 0.05 0.10 0 2089 PPHM 2.00 Oct 19, 2013 0.69 0.55 0.65 0 730
Oct 19, 2013 0.05 0.10 0 1154 PPHM 2.50 Oct 19, 2013 1.09 1.05 1.15 0 20
Oct 19, 2013 0.05 0.05 0 1334 PPHM 3.00 Oct 19, 2013 1.50 1.70 0 0
Oct 19, 2013 0.10 0.10 0 48 PPHM 3.50 Oct 19, 2013 2.00 2.15 0 0
Oct 19, 2013 0.05 0.05 0 319 PPHM 4.00 Oct 19, 2013 2.50 2.65 0 0
January 2014
Jan 18, 2014 0.90 0.90 1.00 0 67 PPHM 0.50 Jan 18, 2014 0.05 0.05 0 10
Jan 18, 2014 0.50 0.45 0.60 0 679 PPHM 1.00 Jan 18, 2014 0.10 0.10 0.20 0 658
Jan 18, 2014 0.30 0.05 0.25 0.30 1 2018 PPHM 1.50 Jan 18, 2014 0.40 0.30 0.40 0 365
Jan 18, 2014 0.16 0.15 0.20 0 4222 PPHM 2.00 Jan 18, 2014 0.75 0.70 0.80 0 63
Jan 18, 2014 0.14 0.10 0.15 0 693 PPHM 2.50 Jan 18, 2014 1.25 1.15 1.25 0 82
Jan 18, 2014 0.11 0.05 0.15 0 765 PPHM 3.00 Jan 18, 2014 1.55 1.75 0
Jan 18, 2014 0.05 0.05 0.10 0 110 PPHM 4.00 Jan 18, 2014 2.50 2.75 0
Jan 18, 2014 0.05 0.05 0 647 PPHM 5.00 Jan 18, 2014 3.50 3.70 0
Jan 18, 2014 0.05 0.05 0 416 PPHM 6.00 Jan 18, 2014 4.50 4.70 0
April 2014
Apr 19, 2014 0.90 1.00 0 PPHM 0.50 Apr 19, 2014 0.05 0
Apr 19, 2014 0.55 0.55 0.65 0 10 PPHM 1.00 Apr 19, 2014 0.10 0.20 0
Apr 19, 2014 0.25 0.35 0.40 0 30 PPHM 1.50 Apr 19, 2014 0.40 0.50 0
Apr 19, 2014 0.35 0.20 0.35 7 PPHM 2.00 Apr 19, 2014 0.75 0.90 0
Apr 19, 2014 0.16 0.15 0.25 0 10 PPHM 2.50 Apr 19, 2014 1.20 1.35 0
Apr 19, 2014 0.20 0.15 0.25 0 550 PPHM 3.00 Apr 19, 2014 1.70 1.80 0
Apr 19, 2014 0.10 0.15 0 6 PPHM 4.00 Apr 19, 2014 2.60 2.75 0
Apr 19, 2014 0.15 0 PPHM 5.00 Apr 19, 2014 3.50 3.70 0
Apr 19, 2014 0.15 0 PPHM 6.00 Apr 19, 2014 4.50 4.70 0
Read more: http://www.nasdaq.com/symbol/pphm/option-chain#ixzz2e8D4KNfY