However you want to characterize it, The PIII trial has become uninvestable IMHO because the results do not conform to the trial design boundary expectations. There is no way to tell if this is due to unexpected control group results, unreliable eastern euro clinical standards, or REO statistical efficacy.
IMHO There is no way to tell - Its a simple dice roll.
Since posting my concern some days ago, I have detected a change in the perception of the events surrounding the NR of September 12th, 2012 by more of the board. The risk/reward changed, some new risk was introduced and potentially new rewards. The old understandings no longer apply toward progression of the science or future financing. More uncertainty now exists and has become obvious in the stock pricing.
I refuse to take part in any bashing as it is at best just immature and adds no value to a reasoned investment decision. If some believe I have bashed it was not my intent rather to raise concern over what changes I perceive or think I perceive. Those changes are worthy of a detailed discussion.
"Since posting my concern some days ago, I have detected a change in the perception of the events surrounding the NR of September 12th, 2012 by more of the board"
bridge, it is self inflicting wounds. It has to do with the character of discussions during summer. Posters were in a way forced to take a guesstimate to be included in the debate. The bad thing is they began to believe in their own amateurish logic and basically drew a line in the sand. They forgot it was a cancer therapy in development. S#!t happens not as an exception but as the norm. Still I agree with nome that we did not have a set back, actually the mets route may lead to wider use than previously thought. Too late to get discouraged or fool yourself about enlightenment. That is one bet that is non reversible.
Sentiment: Strong Buy
I was answering to HGF101. He responded to my question about what would he like to see as a good outcome for the PIIIa data set. I understand the temptation to think that the company changed plans so they must be correcting some flaw in their original development plan. But, they did it right by avoiding the perception that they are applying a retrospective analysis to get the answer they want. This will remain the perception (or at least a possibility in some peoples eyes) until we actually see the data. I have a suspicion that the cheepest entry point will minimally be above $5 after we see the PIIIa survival data.
Sentiment: Strong Buy
Hi Bridger: A nice clarification; thank you. The risk/reward has indeed changed; we didn't see any unblinded data during Sept and the protocal is being changed and that adds to risk. The company is applying to segregate the data into the two components that have been discussed a lot here. The potential reward has increased tremendously if this forms the groundwork for mets only treatment.
On balance; well it would seem that the market has plenty of investors that see the balance going in different directions. The price would indicate that many see the r/r turning negative. I am not wedded to ONCY but I really do like its potential and I don't think that the available evidence on the standard of care supports a supposition that the control group is doing exceptionally well. Different strokes for different folks - good luck to you.
Sentiment: Strong Buy
Teapartyguy, look calling me stupid is not going to solve your problem.
You call it an adaptive design and pretend all is in order when in fact stage 2 is gone. It will never happen, The SPA is gone.
Its like if Togo told the emperor that Hiroshima was part of the japanese plan for victory.
What would it take for it to be investable in my opinion? Sometime in June if Brad announced the analysis was complete and they were enrolling, say 140 addl pts for stage 2?
The outcome fors stage 1 was just a mess with no way to know if BT is trying to make lemonaide or what.
I would like to see Coffey go back through the combo trials and provide some info on the mets only patients. I would guess there are enough mets only in someway help support this new mets focus. The liver mets study done in the UK tell us nearly all mets take in the Reo. We have seen a number of scans with obvious activity in both lung and liver mets. What we don't know is when the mets patients progressed was it do to the mets or progression at the original tumor site? We don't know the relative health of mets only patients and any effect that might have. We don't know the difference in treating mets with Reo alone vs Chemo alone vs Reo+Chemo. This last one may be a question that comes up with the FDA because Reo alone does apparently get to liver mets, see UK study.