Oversold. Shorters called it to their credit from $5+, but its too low given its potential prospects. Whispers of Novartis deal still happening or CHF partnership perhaps? Continued upbeat sentiment on a decent Appendix 4C. I'd bought in more in low $2 on partnership prospects. CHF just too sweet for my liking and as posted the MACE end-points were pre-specified (welcome any insightful disagreement from experts) in the CHF trials and the data-mining accusations without merit in my opinion.
I will not be popular for saying this, but SI and FG in my opinion have done a poor job with GvHD to be at such odds with the FDA (yes they were unlucky with ODAC overturn) and should have been courting many of the FDA apprehensions before the review, not having an at times combative style dialogue with them. They were unfortunate with the tardiness and application of the NIH C-19 ARDS trial, but again, arguably should have been interfacing with the NIH in a more pressing manner when the clear slow recruitment emerged. They picked the wrong primary endpoint in CHF and it took a phase III trial for them to understand the treatment application protocol (that's a phase II learning process).
All that said the failures are well explained and the treatment clearly works, but through circumstance and error have not been demonstrated adequately via trials for regulatory approval. I feel thankfully, SI and FG have at least adequately illustrated the efficacy of their treatments enough to tempt and hold big Pharma. Be it new trials and then approval, or approval with confirmatory trial requisites, they will get there in GvHD, CHF, all-cause ARDS and hopefully other applications.
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