An excellent post Southoz. begrudgingly, I'm back on the sidelines.
The FDA has clearly stated they do not see 'a demonstrated relationship with clinical outcomes'. They do not see the mechanism of actions in vivo or vitro - ???. MSB have a different perspective, hopefully it is convincing enough, but the FDAs comments are strongly worded. Frankly I'm a bit shocked and it was enough to push me to exit today.
The FDAs point 2 in the draft points for discussion is interesting. I read this as effectively asking, is there another way to demonstrate efficacy because at present they do not see it. Yet we see great results in Japan and MSB trial results (which the FDA appears to believe are confounded). I'm really perplexed by this.
I'd strongly encourage everyone to read the FDAs briefing document at least 2-3 times. Don't fall for confirmation bias or simply ignore (or denigrate) different views & negative information, or risk losing your hard earned. There is still plenty of potential with further trials to come, and the ODAC meeting is no certainty either way, but it is clear the FDA has major concerns, and their opinion is the one that counts.
I'll be watching closely in the hope of good news to come. I may miss some massive early moves in share price if the news is good, but the risk is to the downside now given the recent strong run up.
all my non-expert opinion & GLTAH
MSB Price at posting:
$3.83 Sentiment: None Disclosure: Not Held
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