On a conference call many moons ago (June 2020, maybe?) Dr. Jay spoke about their efforts in getting LL in the fight, where after the first couple patients recovered they went to the fda asking for EUA. Then again after a few more. Again after more, and if I’m not too riddled with wine-brain, they went a fourth time too. All over the course of a few months and during the early stages of Montefiore and UCLA. But the FDA wouldn’t budge.
I think the early data, while anecdotal, seemed so obvious and amazing that there was no reason to think the FDA wouldn’t want to do whatever it took to bring LL to the frontlines. That’s how it should be during a pandemic with a therapeutic already shown to be safe and without interactions.
They also probably thought that it was so clearly working that 2 doses would still be fine in trials. Not ideal maybe, but fine. After all, it started working within the first 3 days. People self extubated. People came off ECMO. LL would still shine.
I’m sure they thought it would have no problem showing an effect in mild and moderate patients as well. After all, when it worked (yes, anecdotally) on those first Montefiore patients who were literally the sickest, most compromised patients you could find, why wouldn’t you believe it would work even better on those who were in better shape, with healthier immune systems.
Of course the reality is that it isn’t an automatic cure-all. Shit can go sideways. Down goes Ali, and whatnot. Perhaps that early success played a substantial part in sub-optimal trial design, interim analysis decisions, and leaving the door open for Murphy.
The thing is, as a small pre-revenue biotech I just can’t see how it could have played out differently. The FDA should have helped. The hoops for
Jumping through should have been removed. But now we know how dirty the FDA plays and that was never going to happen. Only in hindsight can we more clearly see the pitfalls of randomization and trial design issues. I don’t blame NP and the gang. I truly think they did the best they could do with the information they had at the time.
I also would have made the same bets. Though raising a little more money along the way would have been a good idea. He probably thought we were always six months or less from significant revenue. I know I did.
I think the early data, while anecdotal, seemed so obvious and amazing that there was no reason to think the FDA wouldn’t want to do whatever it took to bring LL to the frontlines. That’s how it should be during a pandemic with a therapeutic already shown to be safe and without interactions.
They also probably thought that it was so clearly working that 2 doses would still be fine in trials. Not ideal maybe, but fine. After all, it started working within the first 3 days. People self extubated. People came off ECMO. LL would still shine.
I’m sure they thought it would have no problem showing an effect in mild and moderate patients as well. After all, when it worked (yes, anecdotally) on those first Montefiore patients who were literally the sickest, most compromised patients you could find, why wouldn’t you believe it would work even better on those who were in better shape, with healthier immune systems.
Of course the reality is that it isn’t an automatic cure-all. Shit can go sideways. Down goes Ali, and whatnot. Perhaps that early success played a substantial part in sub-optimal trial design, interim analysis decisions, and leaving the door open for Murphy.
The thing is, as a small pre-revenue biotech I just can’t see how it could have played out differently. The FDA should have helped. The hoops for
Jumping through should have been removed. But now we know how dirty the FDA plays and that was never going to happen. Only in hindsight can we more clearly see the pitfalls of randomization and trial design issues. I don’t blame NP and the gang. I truly think they did the best they could do with the information they had at the time.
I also would have made the same bets. Though raising a little more money along the way would have been a good idea. He probably thought we were always six months or less from significant revenue. I know I did.
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