Why, (a) SEPEACITABINE AML results are compelling. Out of 200+ patients who would have died within 3 months otherwise, 30% of the population had complete remission, 35% of population is living after 1 year, even those who died they lived for 7+ months which was higher than the available treatment as on date!
(b) These trial results are RANDOMIZED with 3 Dozing schedule with constant attention by MD Anderson CLinical trials.
(c) SPA will come thru because this is an UNMET medical need. I would expect an ORPHAN STATUS for this Drug in US, if applied for.
(d) On PH 3, it is NO MORE RANDOMIZED, they will choose the patient population based on the Success of Ph 2 trials with 2 successful dosing schedule. This will ENSURE they will very HIGH SUCCESS RATE for an Eventual Successful Ph 3!
Big pharma knows it's success, that is why once SPA is given a Partnership by BIG pharma or BIO is assured!
Ramboti's conf call did state about 2nd SPA, it has to be for MDS. He would not have spelled out SPA, if the MDS trial was not as anticipated. There is a Hidden Clue there, but I'll given in 33% chance as of now!
On Silicilib the way in which information is flowing from across the world from Research institutes, it looks like a Path breaking product!