I've thought about this for a few days and there is a flaw in your argument.

You said Docetaxel performs better on Asian subjects. I'll buy that as I'm sure you can back it up with data, however, here is the flaw; in the p2 trial there were a few sites that raised the bar on overall survival benefit. Being mainly in India, I thought 'perhaps a heavy dose of Asian participants', BUT if that is the case, it only shows that Bavi, too, does well/better with those subjects,.....and that trial was in comparison to Doce as well. With the p3 "failure" and the p2 outperformance (compared to both other Bavi sites and Doce) at certain sites,...to me the question now becomes, 'why were the results so much better in those given test sites', and, 'why did PPHM not review this already to develop a better plan/chance of success for the p3.

I can't find data by trial site......but Bio or someone undoubtedly has it.....

Based upon your comments, are you concluding Bavi is a placebo?

Another question for you....

If the p2 trial wasn't stratified, as you say, and they identified Asians as being more likely to have a positive outcome inside of the designed trial,....why not pursue registration in China???

God knows it would be marketable there.

It will take some looking but I will see what I can find.

You heard it here first folks. Md1225 says MNKD will be 12.20 with ease by year end.

Thank you for your opinion.

Actually, the post of mine before the one you commented on said the same thing. Again, we are in agreement.

I'm not assuming anything. My point was that they don't have a sales force or a partnership. There is nothing to move the stock up and it should be moving down based upon lack of a plan and lack of a sales force.

So, we are in 100% agreement. Maybe read that post again?

Saboteur,....funny.

Considering Garnick is presumably a lot more seasoned than anyone posting on this board when it comes to gaining FDA approval, I can't help butt think the unblinding was planned. How else can the short look-ins be explained?

Time will tell.

Two questions...

1. Given the MOA of Bavi, why would the first look-in be scheduled at it was? Why not wait to make sure separation had occurred/reduce risk that it hadn't occurred?

2. Is there any reason in the world that Garnick may have wanted the trial to unblind early??

Now that you've brought this up, I recall seeing the 'super performance' at those sites and being concerned about p3.

Question; I remember seeing Indian treatment centers reporting much higher/better figures than other sites in the p2 trial data. Is this why?? The Asian/lack of stratification theory?

Like I said, they haven't announced the plan yet. So, no plan.

Making a statement they're going to announce something does little good to shareholders or PPS. It could be a horrible plan, it could be a great one. Time will tell.....but it's not going to move the stock up and no one should be surprised at a decline given the often noted short interest.

Mgmt SHOULD HAVE HAD THIS ANNOUNCEMENT IN PLACE AND READY TO GO ON 4/5/16 so that the momentum up continued. But, no such luck.

With all due respect, how could you think it wouldn't pull back?

They don't have a sales force (are you anticipating an internet sales/marketing campaign??) and they haven't announced a plan to move this drug to patients, educate doctors, or partner with another company who can possibly make that happen. They said they were happy to have it back,....but there is nothing positive about the 4/5/16 announcement.

No plan = no SUSTAINABLE upward movement.

Agreed. Extremely disappointing for many.

INO and PPHM are light years apart from a business model. PPHM is trying to provide reasoning for one drug's approval where INO can create new vaccines to combat viruses in weeks.

Not even in the same spectrum.

I strongly disagree. Just because you haven't sold doesn't mean your current value isn't GREATLY reduced from where your investment began it's journey.

Today is today. Ask yourself, where is my investment today. THAT is the point.

CP,

You missed my point entirely.

On #3 of your reply, I didn't post the entire page because it wasn't warranted (but did post the link for anyone wishing to read it's entirety).

What I did post was specific information to rebut your point that there is no possible negative for the shareholders. That excerpt makes my point completely and concisely and invalidates what you were maintaining. You sir, are wrong in this instance.

CP,

It's 100% a fact that any true long who has invested in PPHM during the last ten years has lost money here. There is no way for that not to happen and that is most certainly not an opinion. Please prove me wrong if you can.

Also, from: http://www.investopedia.com/ask/answers/042015/why-shareholder-rights-plan-called-poison-pill.asp

"Disadvantages of Shareholder Rights Plan
There are three major potential disadvantages to poison pills. The first is that stock values become diluted, so shareholders often have to purchase new shares just to keep even. The second is that institutional investors are discouraged from buying into corporations that have aggressive defenses. Lastly, ineffective managers can stay in place through poison pills; otherwise, outside venture capitalists might be able to buy the firm and improve its value with a better managing staff."

I'm not sure how you can stand by your assertions here, either. The last sentence is EXACTLY what I said myself.

CP,

If it's not under dispute, as you said, then you have to recognize that a hostile takeover, while on the surface could appear to negatively impact shareholders, may actually benefit shareholders. So, it absolutely is in direct response to your comments about the poison pill.

PPHM management has done nothing (I'll repeat that for effect), nothing, to create value for the long shareholders when considering scientific development of it's drug pipeline and PPS. Yes, they have tried and may get an A for effort,....but failure is failure and they get an F for result. By that alone, and possibly in this case alone, having a poison pill in place may actually be hurting long investors.

The only thing we don't know to answer that question is, 'could another company that assumed PPHM through a hostile takeover possibly do any worse?'

I'll leave you with that question to ponder.

CP,

The opinion of many here is that management is stalling/delaying/possibly ruining the success of this company where drug development is concerned while bleeding long shareholders dry. From that perspective, you are definitely incorrect and historical data on PPS and reverse splits certainly bears that out. That is, a hostile takeover may prove to be a boon in this case.

Science is a completely different topic as is 'will Bavi ever be a success'. Ever is not debatable with facts and science may well pass us by at this rate.

The fact is, any long shareholder who has bought in the last ten years is a loser here,.....when considering a hold to current PPS....and PPS performance has been 100% anti-astronomical.

Long, and not proud of it.

I respectfully disagree. Management is the main issue here, but, Bavi has been around quite a while now. Companies either come out with something new and are purchased/partnered or they take a lonely road. The newest issue to contend with seems to be the market. Bavi does have good results with chemo per the p2 trials (if reliable), etc., however,.....the market wants immuno drugs and we have insufficient external data.

How long to generate that data? Will the investigatory partnerships be deemed reliable enough (if they generate positive data) or will a FDA approved trial need to be run?

LOTS of questions.

So maybe parties here, who are looking for an outlet, a savior, can send their letters to Calico instead of SK.

Now trading between .41 and .4101!!!

LOL

WHY, then, can PPHM not apply this same logic with the FDA for approval?

I do not disagree with your logic. However, if Bavi did/does work, the trial design must have been flawed if a 'fail' is officially the result. As many have pointed out, management let us all down here and it's their fail, not a Bavi fail. Therein lies the issue.

I believe Bavi does work, but our team can't figure out how to prove it,.....and I can't help but think the other stopped trial (in 2015) due to an 'outperforming control arm' was also a mgmt fail.

To the best if my knowledge, the partipants inside of NCCN stand at 24. I do not hope for studies from all but it would be nice and is a possibility.

27 came from those 24 plus PPHM, AZN, and UTSW.

The point being the relationship adds a lot of potential researchers for (comparatively) little $$. That,.....is a very good thing IMHO. The other thing that is good is that with different groups, you have different viewpoints. Perhaps someone sees/explores a completely new direction that aids profitability down the road. Who knows.

It sounds to me that they are maximizing the opportunity at hand and 'selling' the only positive they have to sell after an unexpected and fail.

Smart on both accounts.

Amen. 100% agree.

Getting drugs approved through the FDA vs simply manufacturing a drug that is already approved are two vastly different things.

Call it what you want but this IS a very valuable 'partnership'.

There are 20+ facilities with accredited researchers who live to publish data and discover new things. A publication from this group could be worth it's weight in gold and we now have 24 research teams working on discovery, instead of PPHM, UTSW, and, potentially AZN. For a measly $2,000,000????? Think of what they have spent on their own overhead in the last decade.

27 groups vs 3. Which is better here???

Yes,......we'll see. I, for one, am scared.

There's a lot of that going on PGG.

They started down the chemo path years ago. It wasn't a recent decision.

That said, if the doce arm hadn't outperformed, who would be complaining right now?

Thank you ..... And great to see you posting more!

One last thought; From everything I've read, our phase 2 really was a phase 3 trial design. The only thing that gave doubt to the data was JB. So, we have 'phase 3' results (from that phase 2 trial) that have been deemed acceptable by the FDA.

Considering JUST the Bavi arm of sunrise as support for the phase 2s results,.... which should support the p2 trial's success,......why couldn't PPHM silently, below the radar, no pr,....file for approval?

Yes, the p3 control arm has to be mentioned and should be mentioned to the FDA, but we would have two trials/arms to prove Bavi works regarding safety, patient benefit, etc., and a decade(?) of Docetaxel literature/trial results to prove the control arm here was not only abnormal but grossly high. Nutshell: Bavi continued to work as anticipated, the trial didn't.

To me, the drug would gain approval if the p2 data was acceptable. We have safety and we have Bavi as acceptable.

I don't care if we are immediately SOC. We have an approved drug that can be added to treatments now.

.02 and IMHO.

Thanks doc.

To be clear, I was hoping preliminary p3 results for the Bavi arm would support p2 trial results.

The p2,.....was a p3.

In your example,....if you made a bet your horse could run the time it ran, would you consider that valuable? (Rhetorical)

I agree the trial itself was a failure but benefit can still come from data collection.

One thing; in all of the reading I did this weekend on the BLA and NDA approval process, not once did I read a drug needed to have a 'successful' p1,2 or 3 to be approved. Instead, they settle on these first (per the FDA, link below);

"Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity."


Lastly,....please view page #19 2 and 2a. This certainly seems to suggest it's possible to acquire approval without the need of a clinical trial. But,....2a shows that multiple studies where results are consistent is a positive. (I think now of our p2/3 as having possible comparable performance based upon "performed as expected")

While I definitely respect your opinion and thoughts, it seems it IS, at a minimum, possible.

Reading link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078749.pdf

CP,

Is it possible the deal was already in place and the defining factor is how successful sunrise is or isn't at the lookin's?

I.E. X is paid after sunrise completes. 10X is paid if successful sunrise

The one thing everyone seems to forget.....is that Bavi isn't competing with any one drug or class or drugs. It's there to make those drugs work better.

Big pharma shouldn't have anything to fear. They should embrace the technology now to be first. That's the smart play for them IMHO.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078749.pdf

"d. Studies in combination or as monotherapy For a drug known to be effective as monotherapy, a single adequate and well-controlled study is usually sufficient to support effectiveness of the drug when combined with other therapy (as part of a multidrug regimen or in a fixed-dose combination). Similarly, known effectiveness of a drug as part of a combination (i.e., its contribution to the effect of the combination is known) would usually permit reliance on a single study of appropriate design to support its use as monotherapy, or as part of a different combination, for the same use. For example, a single study of a new combination vaccine designed to demonstrate adequate immune response will ordinarily provide sufficient evidence of effectiveness if the new combination contains products or antigens already proven to be effective alone or in other combinations. These situations are common for oncologic and antihypertensive drugs, but occur elsewhere as well."

"Substantial evidence was defined in section 505(d) of the Act as “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”

A serious question for the board...

Many here have claimed that, had our p2 trial (which was actually a p3 designed trial) not had issues/sabotage, we could have been approved by now.

Given that trial's data reconstitution and a (hopefully) positive showing in p3, with Bavi performance validating the p2 results, would the FDA not use a little common sense here and allow approval? Considering all data at once, we've essentially run two phase 3s, have excellent results in one,.....and may have great Bavi results in another with a freakish control arm as the only detractor.