To: Littlebits who wrote (12871 ) 5/23/2014 4:18:31 PM From: boomertree2 1 RecommendationRecommended By
Read Replies (1) | Respond to That's the question, what is the next step? BTD was never a separate pathway for approval. BTD merely created a process whereby the FDA would work closely with the company to design the quickest pathway to get the drug to market, which could include endpoints such as tumor ablation rather than long-term survival, and shorter bridging studies with a smaller patient population, rather than a full Phase III multi-year trial. Without BTD, we don't have special FDA consideration. We don't have special endpoints. We don't have an FDA agreement on a shorter study with fewer patients. Where are we? We shouldn't be back at the same point as 2010 when the Phase II trial ended as we now have the Mofitt studies and compassionate use results. How much progress did management make with the FDA regarding SPA and Phase III trial design before shifting focus to BTD? Thats what I want to hear at the 4pm call. My lack of confidence in management has magnified. One of the other blog sites reported the FDA denial letter was dated May 21......did management receive email notice on that date? If they did, and failed to report it, all those shareholders who bought and sold during that period and incurred losses, will likely be seeking recourse. If management knew of BTD denial on the 21st and rang the bell to open the NYSE on the 22nd, that will pour salt in the wounds of shareholders buying over that period. Also, proxies to approve the new management compensation package were also solicited and collected during this same period......I imagine all the management BTD application announcements over the last few months also encouraged positive votes on the new compensation proposal. We may have a stronger case for liver PV-10 BTD and quicker approval at this point.
