as I understand it from the history the pivotal hvc trials were based on several consistently good but small 20 to 40 patient phase 2 studies. the fda must have agreed to the design and the lack of not having larger phase 2 trials first. the large number of patients in both phase3 hcv trials suggests that achieving significance over the control group should not be too difficult. the absence of ribavirin imo also does not concern the fda. safety is apparently not an issue. fda only cares about efficacy data and safety not sales. but scln has to be concerned with sales and how to fit zadaxin into the standard of care. it is no surprise that scln has no large us corporate partner/endorsement as there is no large early us data to evaluate. people like adam walsh and investors like us have the same problem. if the results are at best equal to peg interferon plus ribavirin in the same population but safer than scln will have an interesting future. and cancer uses could be bigger than hcv. As for ssk34�s wish for $8 how about nobody sells anything for just one day.
actually sigma tau with their milestone payments has to be a partner of sorts......what you must be speaking of is a U S marketing partner.....there might likley be more than one. depending on usage????.these are good thoughts as they presume a viable product and the staffing up in the US certainly suggest a confidence of approval. Institution would be the likely buyers at this stage and marketaility and average daily volume become important...Scln is a roach motel until it has a product and real sales......then its the Ritz Carlton...Those who want marketability need to wait til after the second split ...as for me Id rather own at the bottom and wait. thanks for the good thoughts
>>if the results are at best equal to peg interferon plus ribavirin in the same population but safer than scln will have an interesting future.<<
We hardly need to revisit the fact that we are dealing with a patient pool of nonresponders. But if you're suggesting off label use for all hep C patients, then we'll likely have to wait for a triple therapy trial before doctors feel comfortable with that. Now cancer, however, that's a different story (urgency & desperation, combined with aspects of a bolstered immune system and clean safety profile, may well deliver a steadily rising percentage of off label use for various cancers).