Anktiva commentWanted to add in comments to the Anktiva conversation.
The approval process was way longer for this drug because it was biologic. Ruvidar is not so faster assessment process for production process with lower chance of being CRL'd for factory issues.
While the stats look good for the CR while on the drug, they have not generated stats on longer term CR once done the intensive phase. When TLT gets the longer term data, if it shows that the CR continues to hold then that puts it into the unique category of drugs that don't have steady CR fall off after the first year. I love how all the continuous CR's that go CR from 90 to 360 seem to hold at 450. I feel like that sustained CR is the key to BTD and AA more than anything else.
One other challenge with Anktiva is the tethering to BCG. We know that uro-oncologists are struggling with the supply issues such that a lot of first round patients are under-treated with BCG compared to gold standard. So now we are saying that all those BCG failure patients need to be enrolled back on the BCG supply wagon. For now, where is all this BCG going to come from.
IBRX was smart to market the drug has having potential to work on other cancers but it is not convincing that it would work that well. Bladder is unique. On the other hand TLT has some great data on how versatlile their compound library may be.
So all in all, I'm just waiting, as we all do here. I do hope that the next patient update includes some extended results on the CR as we go further out. They don't have enough/any new patients to impact the 90 day CR numbers at this point.
GLTA