I am not familiar with the Wells case but the Chardan case seems quite defined and I don't think an announcement should have an effect. I am thinking and hoping they want the vote for share auth. expansion to be conducted post positive news, which makes it much easier. I try to remain balanced but FDA can beef up their 2017 approval numbers with this monumental (risk free) approval. I see Gottlieb holding his staff much more accountable than prior management/administration. I would not want to the be lead investigator on DCVax-L if FDA has been the cause of any delay. If on the other hand all delay has been NWBO's choice to strengthen their data, I believe they have all they need now for approval and reimbursement and can still concurrently gather more. This should be in the new FDA sweet spot now. I think the company is focusing on reimbursement specifics. It is also a candidate for a rolling submission, which I think started a few months ago, when they hit the expected 233rd event, regardless of whether it happened. The company has final say to end the study and not FDA regarding a positive effect. I think it is coming together between NWBO and FDA.
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