<.001 and .5 is just weird.>
As you know, this grouping of disease is not well understood, a mix group of patients with real differences give you this kind of results.
I also believe that they can get a partner for this drug because the usual suspects have cash and their needs are such that they don't mind throwing some money to get in line. So to me, a partner would not be validation, but just shows the need of the partner and the worth of this market. But the knee jerk reaction is going to be partnering is validation.
ITMN should obviously go after someone who would fund the next phase 3 trial. If I were a single partner, I would want both the US and EU to fund the next trial. Other than that, I personally think that if ITMN partners both EU and USA seperately then they are telling us that the chance for approval is low. Unless somehow they needed different partners in EU and USA to fund a single trial which would be quite unusual.
If they don't partner, that would tell me that they are nuts but they believe in their own talk. I believe they will want to partner the drug now.
I said fish or cut bait because I think they need 2 more phase 3s, not one. My guess is that the chance of 1 more trial being positive is probably not that much better than 50/50. If they do one more trial and it bombs, the drug is dead. But I know they won't do 2 trials. Unfortunately there are patients who can benefit from this drug.
So why don't I think the FDA and the EMEA will approve? It is the same reasons as always. There is not enough SCIENTIFIC evidence that this drug works in the intended population. Most of us have gone down that path before so I am not going to rehash. Unless there is a change in the way the two agencies look at scientific evidence, I don't see approval. The Japanese trial is not going to help much in this effort because of it's own problems. If the Japanese trial was always supportive, why didn't ITMN just do one trial? If the agencies want to approve this drug, they can. But people run agencies and I don't expect them to change their standards/methods unless they show me behavior changes.
Here is a dumb non-scientific way of looking at this that may mean something to some people. Let's say we have 3 parallel worlds in which in one ITMN ran two parellel trials but the other two the ITMNs ran consecutive trials. So world one ITMN get p=.5 and p<.001 in two parellel trials. They file saying it is good enough. FDA gives ok? In world two ITMN runs one trial and they get p=.5, totally random answer. ITMN shows the analysis and say they want to run another exact same trial. People tell them they are crazy but they do it anyway. They get p<.001. Should do file? FDA gives ok? In the third world ITMN runs one trial and they get p<.001. People dance, maybe they file accelerated, maybe they do rolling, telling everyone all they need is a "confirmation" from the second trial and they are so sure, etc., look at the first trial, p<.001, 1 in a 1000, etc. etc. The second trials get a p=.5, a nothing answer. FDA gives ok?
The answers should be the same in all three worlds because the only change is the time relationship between the two trials. If the answers are different in someone's mind then something is not right.
<edit> If the agencies want to say no, they can always find ways and reasons to say no. And vice versa. An advisory meeting does not always give a truly independent answer.
<reply> No, I am out of my positions after doing some early trading. Made enough to buy my own tarp for shelter. :) |
