"That was the plan last time according to many on here and we all know how that turned out after claiming what a "position of strength we would be in" after an FDA approval"
Why the sad face. We new what would happen in the event of a CRL. Cash in the bank would not have made that much difference. I know some that made a very handy sum on plan B. Including you. Others , well perhaps they may be more prepared to inject cash on similar investments that stumble.
Anyway today news is fantastic, multiple sites open.
I will be keen to see enrolment progress as I think many see CLBP as been way down the road. I however think it could be far closer than many think. It was mentioned some time back that the trial could be quite small to show significant results. DSMB would be keeping a eye on significant results. Control should be able to get treatment as soon as effect has been shown to be significant. 3 month results of about 30 treated would be very hard to question efficacy if they came back similar or better than the last P3. Fine tuned confirmatory trial should show significantly better results.
What will tomorrow bring? 30 days in from GVHD BLA , 30 day before decision would be great!!
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