My first e-mail to Bernie, and I was very impressed with the brevity of his response and its content. Here it is:
Our stated milestone is that a phase I will start in 2Q 2014.
This product and trial have nothing to do with Roche, which licensed hep B and prostate.
We’re also looking forward to seeing this third product in our “cancer portfolio” move into a human study. It will be another step toward the overall process that we have spoken about: at the R&D level we are in identifying and will advance an even broader set of antigen targets that we believe offer significant potential in different combinations to target virtually all cancers. There are typically multiple possible antigens related to any particular cancer (or infectious disease, for that matter). (Antigens are simply proteins associated with a particular cancer or infectious disease that the immune system can recognize as being “foreign.”) Different antigens are associated with different cancers and, like hTERT, certain antigens are associated to greater or less degrees to multiple cancers. So when we design the individual DNA plasmid “constructs” that contain the code, or instructions, to produce a specific antigen in the body, we can mix and match them to create an optimal set of targets to activate T cells against a particular cancer.
Achieving the efficacy proof of concept for our technology with the phase II data was an historical step for our technology, our company, and the field. It’s onward and upward. From here.
I’m sorry to hear about your friend.
VP Investor Relations & Communications
858 336 5579
Possible, but Q3 2015 at the earliest, for reasons elucidated elsewhere in detail.
I generally agree with many of your posts, detriever, but your analogy of airplane flight risk to biotech PPS risk, is way off base--even for INO.
There is inherently WAY MORE RISK with ALL biotechs than with ALL airplane flight. If you don't get this, well, you need to rethink and restudy some things. LOL.
We've definitely gotten off the ground, but plenty of risk remains before landing. :)
Let's see if we can fly around the storms! :)
Having dreams and hopes is a good thing.
"Maybe big pharma just waiting to make sure INO's P3 trial protocol (and intent-to-treat group) is okay'd by FDA before they make a concerted effort to partner…"
This is it in a nutshell. P2 will not close until mid-year, 2015. Peer review paper not before Q1, 2015. FDA protocol for P3, not before Q3, 2015.
While partner discussions are likely going on ALL of the time, any formal offer WILL NOT come before Q3, 2015. Mark it.
Yes, we could see some good news this fall, but I doubt it will be leaked peer review data.
How can you say that when the head of investor relations has said it's a minimum of "months away." September is weeks away.
Trust Bernie, there will be no leaks of data.
I'm anticipating a "nice" Christmas present, but no sooner than that.
We've seen no information about this trial over the last few weeks. It was not discussed by Dr Kim during the last CC.
Is this P1 trial still due to be initiated in 2014? Aren't part of our Roche milestone payments based on it's beginning?
This is the trial that MANY of us are most interested in, as the hTERT expression is found in 85% of all cancers and this could be part of a universal therapy for many of them. At a personal level, I have a close friend who is suffering from lung cancer and I for one would like to see him no longer dependent on chemotherapy.
Is this very important trial it still part of the INO pipeline? Many of us would like to know. Both as investors and for its potential health benefits to a broad swath of cancer patients. Can you provide me with an update? Many thanks in advance!
The INDEPENDENT peer review is at least several months out, according to Bernie at investor relations. More likely after the first of the year.
A positive INDEPENDENT peer review is something that could drive the price MUCH higher.
Dr. Kim's open market purchase was nice, and likely put a floor in PPS ($9, $2.25 pre R/S), but he's a biased player in the game, as should be obvious to ANYONE with a mind.
Again, a positive INDEPENDENT peer review is something that could drive the price MUCH higher, but it is not likely for months. The head of investor relations has said so. So it must be. That's the reality, folks.
I hate to burst your bubble, but the independent peer review will tell us whether to "load up."
Dr. Kim's purchase likely put a floor in the stock ($9, $2.25 pre R/S), but it proves nothing as he is a biased player in the game (for obvious reasons).
That said, I remain long and cautiously optimistic, pending the peer review of the data.
I agree detriever. A buyout offer would be the ONE catalyst which could overnight produce a share price of $50/share.
But any such offer is at least a year away, IMHO. There is a lot of data to vet and other trials to get started in the meantime, however.
I understand your point of view completely, too!
I believe that I'm going to do just that.
I have a friend who has lung cancer, and I am recommending that he become part of this clinical trial, if possible.
I'm long INO but also a realist.
Even in the best of all scenarios, we won't see $50/share for a couple of years. Now, don't get me wrong, that's still a helluva return from current levels.
But my point is that there is "plenty of time" to get shares while they are under $50. :)
Nonetheless, this is a VERY important trial, which I thought was to commence sometime in 2014.
No one seems to know anything about it's timeline anymore.
The one thing that many of us are looking forward to is the vetting of sub-group data.
That will help INO propose a P3 trial which has a much greater chance of success.
And who's to say that the treatment has to arbitrarily stop after a certain period of time, so long as the clearance percentage gets even better with more administrations over time.
We should know a LOT more by early next year!
Sac--we're not in disagreement here. This is still a highly manipulated stock.
My only point was that Dr. Kim didn't fully communicate all of the details that many of us were expecting during the CC. That's all; nothing more.
I couldn't agree more.
What percentage of the stock is still controlled by retail? By institutions?