@A_May_MD Helpful take! I think one thing you're missing is that their revenues already exceed cash cogs and sgna. The only reason they are reporting losses is the RnD aimed at next indications. Curious why you're choosing to not make that differentiation.
@seedy19tron I think you might have missed the point on $IOVA Unless you have a clear view against their upcoming NSCLC data update, that short doesn't make a ton of sense to me. If you do, I'd love to hear it!
$REPL the approved label cites 24.2% ORR and 14.1-month median DOR, materially lower than the 34% ORR/24.8 month DOR the company had been touting. That's not a new dataset, it's the same IGNYTE data. Still overall, the best outcome they could've gotten imo.
$IOVA I run a line item on my model that calculates the profit margin exc. RnD expenses. This is the second quarter where IOVA generated a positive margin on that metric (+16.6%). The only other instance is Q4 last year (+8.6%)
@jy201506 Spot on. The point of discussion isn't should people have access to it. The point is who should pay for it. And the logical answer should be that the company that hasn't presented sufficient proof should bare the cost until it proves otherwise.
A confirmatory readthrough for $IOVA from $REPL ad com: MD Anderson is one of the larger ATCs. If they are estimating 100/200 TIL patients, and there are roughly 10 large ATCs. That's at least 1000 infusions from just 10 ATCs. I.e. demand is strong irrespective of rp1 approval.
That's true. I agree that should be the logical conclusion. It really comes down to how much muscle fda is willing to put behind it. Im thinking fda doesn't have a leader, appetite for dealing with blowback...who knows. REPL couldn't put a trial together but 10/10 for advocacy and politics lol
@BIOTECHSCANNER Its going to be literally the last option imo. Can't possibly compete with any other approved product at this stage even if it gets the approval. Any reasonable oncologist seeing that video would be looking to exhaust all other options before reverting to such unreliable data.
@GregY_Market That's a fair comment. I'd add that there were elements of the discussion focusing on how there could be harmful effects as well. I think that addresses the question of why it should not be approved even though the patients don't have alternative options. $CAPR
@A_May_MD I've had a soft rule that if someone has to use surveys to make their point, the point is pretty weak. This has worked especially well for sell side surveys!