The FDA has indicated that this issue will require remediation in order for the application to advance
to full review. The FDA has not indicated any deficiencies in the clinical or nonclinical data relating
to the safety or efficacy of TLX250-CDx2
.
I think it de-risks it a lot hence the SP marching back up, but based on the above "It's not over until the FDA sing"
However, they have gone over the whole application and have one issue (potential production sterility issue). Once we address it and the CEO has said we can, it can "advance to full review"
This is the only thing they found, and in 30 days they will get together and discuss the solution together.
TLX250-CDx2 is a much-needed diagnostic treatment the world needs and I'm sure the FDA is of the same opinion, that's why they get a rolling review.
The panic got it wrong this morning.............. AIMHO this has been de-risked today.
GLTAH
The FDA has indicated that this issue will require remediation...
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