To: erickerickson who wrote (47743 ) 11/23/2018 2:59:08 PM From: allatwwk 9 RecommendationsRecommended By bobbseytwins2001 chandler27 EMU2 idahoranch1 JJINV and 4 more members
Read Replies (2) | Respond to of 63326 in order for 132 not to get AA, someone at FDA is going to have to say something akin to the following: "Yes, 132 has notably better efficacy than the alternatives and yes, 132 has a notably better safety profile than alternatives and yes, there is a significant patient population in dire need, but here's the 'problem ..." I have a hard believing that whatever follows the word 'problem...' in the above sentence is sufficient to derail 132's approval. Since the top 3 current problems for 3rd line tnbc are 1. efficacy, 2. safety and 3. the large number of patients in need. You can make a major dent on all 3 by getting 132 to market. Absent some mountain-sized problem we're unaware of, you don't stop these patients from getting treatment. I'm optimistic the FDA sees this rationally. Meanwhile, we've parsed Pehl's cc words up here and the interpretations are mixed. But when I parse the actions coming from Pehl and his team, there are no mixed signals. They give off one very consistent signal, they are confident in 132's approval. My one concern on this front is that IMMU's mgmt is simply overconfident. I don't have enough history with them to know if they might fall into this sort of thing. Nothing is a sure thing, but there are just too many good reasons and positive signals for me to be skeptical over 132 and AA at this point in time. Here's hoping we see approval soon. It'll be nice for our wallets. It'll be far more meaningful for the patients (and their loved ones) who can get the treatment they so desperately need.