I actually feel kind of shell-shocked and in a daze - and it's not from getting no sleep for 26 hours straight.
I have believed wholeheartedly in this stock for so many years. The science is there. These little beauties WORK. So to see the share price get unfairly beaten down over and over again, to read crap articles in top Australian mastheads bashing it down, to have to endure the gloating of these ruthless downramping POS trolls (my fingers cannot move to ignore fast enough).
Ugh, it just wears you down, you know?
When the SP got smashed on Tuesday, and we all spent the day poring over the FDA briefing notes, which, let's face it, did NOT look great for our dear ol' MSB, man, that was the pits. It was much worse than the drop earlier this year, where we knew we had positive things ahead of us (including our lay-down misere, AGVHD! That's our easy one!).
No, this one, the AdComm, was real world. And if it failed, it was going to be a big setback, even if there were still paths through to approval (by the very same agency that I kind of feel tried to stitch MSB up in this process, really).
And even if ARDS was still out there as a possible "win"? Well, that was more weeks of anxious waiting, and SP disrespect, and crappy articles, and ruthless trolls.... Wash, rinse, repeat.
So sitting there, glued to the screen and hanging on every word--particularly as an ex-trial lawyer, was NERVE WRACKING! Because that's what this was - a trial. With the FDA--the PROSECUTOR!--running the show. The "questions" were written in the classic Catch-22 style: "SI, have you stopped beating your wife?"
Listening to the panel get things wrong time and time again, and sensing (just a hint of) frustration on SI's part in the morning was also brutal. Yes, our team SHINED. But the AdComm folks were NOT GREAT. Ms.Halabi, she of the 51-49%, could barely formulate a question and make herself understood. The great relief in the tension came when one of the doctors, maybe doctor Sung, basically told the FDA that they, the AdComm did not actually have the expertise to give them any input on the manufacturing and proof of potency questions! And that's correct - I would say not a single, substantive suggestion for MSB to improve batch consistency, identify and deal with heterogeneity, etc., were put forward by the AdComm. So the morning was a waste of time really, instead serving as a showcase for MSB's depth of knowledge and experience. Guess it at least put the AdComm's mind at ease that these weren't chancers.
The afternoon was an entirely different story, with questions, when read out loud by the FDA rep, that seemed to be DRIPPING with contempt for MSB's pathetic single-arm trial. Fortunately, one of the docs on the AdComm had done their homework, and went in for the kill, asking the FDA to explain Jakafi's approval in light of the inferiority of Incyte's trial and trial data in comparison. Team FDA SCRAMBLED to try to duck that question, but when what's coming down the track is a Mack truck, there isn't really any place to go. The one chucklehead clearly designated to fall on her sword for the team on this question sputtered some nonsense about it not being relevant in this context, and it being the AdComm's job to only look at the case before them...but you could tell that the AdComm was NOT impressed.
Then Fred Grossman stepped up. Jesus, if I ever need anyone to defend me for some crime I committed, I care not a whit if the man has no legal training, I want HIM for my defense lawyer. Smooth, so freaking polished, with tone, tempo and pace perfectly suited to his subject and his slidedeck. Amazing. It was like watching an artist working in their medium.
Dr. Kurtzberg, though, really brought home the bacon for Team MSB. She, too, was eloquent, but more importantly, passionate. She brushed aside any B.S. about RCTs in this context: "My patients know MSCs work, they are NEVER going to agree to risk getting a placebo, and frankly, the one to two months it would take for the trial would lead to potentially fatal outcomes, regardless."
The public speakers at the end, particularly the mother of the young football player, amplified Dr. Kurtzberg's description of the disease's ravages, and made clear just how devastating this disease was, and how life-saving and effect Rem-L was. I know Hinrichs didn't cry, but I cannot believe anyone else on that panel had a dry eye.
Turning to the discussion of the questions on trial design, and strengths and weaknesses in MSB's 001 Trial, I was feeling great...until Hinrichs stepped up. Again, dripping with contempt for this pathetic single-arm trial. At that point, and with Halabi all over the map, I really started to have grave doubts. But the rest you know.
Waiting that 10 minutes for the voting results was tough. But the results make clear that whatever doubts the FDA tried to sow in the AdComm's mind (and yes, there were valid concerns), they could NOT deny the clear outcomes, and the voices of the clinicians speaking so passionately and eloquently about the difference Rem-L made in their patients' lives.
At this point, I don't care AT ALL about SP. It's just nice to know that I haven't been living in an echo chamber with fellow cult members here on HC.
We were right--the science WORKS. And the AdComm couldn't deny it.
Now, hopefully, the FDA cannot either.
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