Haven't posted in a while. I have a little over 1
Post# of 148166
I'm an overly optimistic skeptic.
Help me here....I really don't think they will submit the BLA in the next 60 days. Seems like they are looking for an alternate strategy, such as the BTD, or waiting to get excellent, consistent cancer data on a reasonable number of patients.
Right now, they are reporting different items on various cancer patients (who have different types of cancer and are in different "categories.". Why are they reporting CTC's for some but not all. Why reporting EMT's on some and CAMLs on some? Sometimes, they seem to be reporting the sum of two of these items.
They have "96%" (my number) committed to submitting at least one part of the BLA almost every month since September (or earlier). Yet, they haven't submitted either of the remaining two parts. As I said, I don't think it will happen in the next 60 days. Something is holding them back.
If they get BTD, does that offer a different route to approval? Don't they EVENTUALLY need to submit a BLA? (And, no, I do not believe all of the excuses, such as blaming FDA or manufacturer. They have said it will be submitted in 4 days and then missed the deadline. Really strange.)
Of course, some will ask, "why are you still here?" Greed and/or stubborness or FOMO. I can afford to lose 100% and would hate to miss out on a miracle.