RE: RE: RE: RE: Patients' compliance Cat, I can only provide you my guesses.
First, from BNC website, quote "Bioniche initiated its Phase III bladder cancer clinical program in November, 2006
The objective of the first Phase III trial is to evaluate the efficacy and safety of Urocidin™ in patients with non-muscle-invasive bladder cancer (NMIBC) who are refractory to intravesical Bacillus Calmette- Guérin (BCG) therapy and at high risk of progression. A total of 129 patients were enrolled......."
So you see, the data Euro received from P3A are on refractory patients.
So I guess Endo decide to design P3B based on refractory population are as follow:
1. Its better to build on existng successful data. With a larger samole size, more convincing to the FDA.
2. Take the uncertainty out: Urocidin does not have a clear comparison against BCG. There is a chance that the trial might show Urocidin is not as effective , or only has marginally better effectiveness. Would FDA approve Urocidin based on that?
3. BY proving MitomycinC ieffective, they can kill two birds with one stone: Urocidin approval and wipe out Valstar's competition.
4. $$$$$ Refractory drug can fetch higher dosage fee.
5. The BB neurotic Coinspiracy theory. They want to use a failed trial to eliminate Urocodin as a competitor to their Valstar. (A very laughable notion if you ask me)
I do have a question that puzzles me and bothers me also:
If BNC thinks that they can now convince the HC to give us the NOC/c based on compassionate reason using their limited P2 and P3A results without any trial to campare to BCG directly, why didn't they do that two years ago?
Ron