So I am wondering about the STRUT test data reported a few weeks ago. What is meant by "Topline Data" and why do you think more data details regarding STRUT have not been forthcoming? Gives me a bad feeling actually.
I am like you on this one...I suspect the best possibilities currently are "c" and "e"...and perhaps the ability to participate in a potential blockbuster drug at a reasonable price !
It'll take them 60 days just to root cause current validation issues and come up with a rework/ reprocess game plan...then they have to execute successfully three times in a row and then be able to sell it to the FDA...going to be a long time, I fear.
I agree...its a long term process correction issue with possible additional setbacks...the longer delay will slowly eat away at stock value...better to put your money to work elsewhere...
GMP and process validation concerns are nothing to sneeze at. 2 Months turnaround is a pipedream to correct validation shortcomings. Assumes everything goes well and then FDA buys into reasoning as to why batches failed in the first place. Not confidence-inspiring for sure!
Unfortunately, this management appears to have a habit of stalling...beware the Ides of March...
Me too...closest out my AMPE position...going to NWBO too! GLTA.( thx for the tip on NWBO...looks real promising!)