Okay. My daughter's soccer trainer died this morning from cancer. I bring this up not for the sympathy, but for an illustrative point. I'd like to chime in on some points Mojo, Firefox and others have been making.
Mojo pointed out that Herceptin competition may be in play. And, Firefox pointed out that things might get moving as data in the lung cancer phase II, plus IST data starts to roll in. Good points.
Personal opinion is that PPHM has too many irons in the fire to fail at this point. Something is going to hit. From bavi AC and AV, to Cotara, to biosimilars, there is a lot of potential blockbusters. I usually don't like to see small companies be this diluted in their efforts. But, PPHM has managed to progress several programs without "massive" dilution as a result of Avid revenues and focus. Did the shotgun approach slow them down? Maybe, but it also has strenghened the end product. No longer should the company fail if one test doesn't turn out as hoped.
So, what's the value driver? Garnick summed it up in a conversation at the ASM. He said, PPHM has got to get "that first product approved. Then things will take off." Somewhat common sense. But, this was coming from a man who took the ride at DNA. DNA got a product approved. It funded future research and when AC products (Avastin) was approved in the initial indication, off-label use expanded the returns and multiple new use trials commenced.
Another point Garnick made in his presentation at the ASM is that it's hard to get the FDA's attention if you're not meeting their needs. He told of how they got an early product through FDA in a matter of a few short months. Of course, the FDA called DNA wanting to know how fast they could develop and get data on the product. So, bottom line to the story is that if you're working on a key FDA issue or unmet need, you'll get the FDA's attention. Hence NSCLC - an "unmet need". And, the keystone to PPHM's current strategy. Sure, Cotara would be nice. But, get data comparable to the early phase II's on NSCLC and, "let's talk".
Personally, they can't run the phase II NSCLC trial fast enough. And, any IST trial adds more data points. But, the key is getting that first approval. Like Firefox postured, will BB or BP want to wait if data is looking good? Or, is PPHM really intent on getting a product approved and trying to duplicate the DNA model? Who knows. The longer it goes, the more this management team will need (moneywise) to walk away. And, in discussions I've had with them, they are already talking big numbers. Geo - you're not close to their current thinking.
Numbers aside, I want/need PPHM to put something across the finish line so the pace of development can be funded and vastly accelerated. Too many years ago, in a discussion with Golfdad (anybody remember him), I mentioned that if I had cancer, I'd like to use Cotara to sock the primary tumor and then use a VTA agent to clean up the reamining blood vessels that haven't been cleaned out of the tumor/cell interface. GD agreed this was a good idea, but cautioned that trials were complex and couldn't be too complicated because it would be difficult to tell what agent is doing the good.
Years ago, I also mentioned that I liked the idea that PPHM was going overseas to save money and that I was glad they were using Bavi as an "add on" to SOC chemo. My comments weren't made because I didn't want "loaded" Bavi. I personally think that loaded Bavi is the future and I can't wait. I also personally think that standard Chemo that essentially carpet bombs the body is barbaric and I can't believe we haven't progressed beyond this. However, at the time, I didn't think PPHM could take on the Chemo industry and expect to gain approval. So, get Bavi approved as an adjuvant and then let's get to loaded Bavi.
Back to the soccer trainer. He had kidney cancer several years back and one of his kidneys was removed. Cancer returned recently in his kidneys (initially) and then in his liver, bones and spine. He initially qualified for a kidney trial at MDA and things looked good for a while. Then things started to progress. Things really took a turn for the worse when he started to lose feelings in his legs. Tumors were found in his spine. So, he underwent spot radiation treatment. More tumors were found to be affecting his arms and mouth. So, more spot treatments. Then, a couple of weeks ago, his wife reported that the Onc Docs were going to treat him with Avastin. Avastin??? Why not? Let's not give up.
Two points to this. With what we know from Bavi's moa and pre-clinical trials, if you'd just had several rounds of radiation, would you rather have Avastin or Bavi as a last chance shot? I know what I'd want. Second point is how pervasive off-label use of Avastin is. It's approved and supposedly safe. Why not give it as a Hail Mary. Well, it is expensive for one. But good for Roche I guess.
So, where's all this going? Well, instead of sitting here daily responding to the technical analysis highjackers, or worrying about the Russell rebalance games, or whatever the negative theme of the day, I sit here and sincerely hope that PPHM can expedite the move towards a first approval. If they advance the ball quickly and it leads to PPHM becoming the next DNA, or whether it leads to a BP/BB buyout or partnership is irrelevent to me. I should profit financially either way. If everything fails, I'll lose some money. But, the potential for these "platforms" that PPHM is sitting on is too groundbreaking and valuable (IMO) for mankind to waste. That's why all eyes will be on Garnick and the NSCLC trial. Like Firefox, I believe the pace will quicken once patients get treated and confirmation data begins to come in. If it's good, watch out. Even though I can wait for many more years financially, I want to see the pace quicken (and it will with good phase II data) for the sake of all those great people, like my daughters trainer, who have so much to give and leave too early.
Regards,
WHJ
AI
