You are co-mingling and confusing FDA law with securities law.
The FDA, by law, will not disclose information contained in a sponsor's BLA. Generally speaking, communications between the agency and the sponsor are privileged and confidential.
In practical terms, if you call the FDA and ask, "Did NWBO file a BLA?" The FDA will say, "We can't tell you."
The FDA discloses drug approvals. We've all seen press releases issued from the FDA's media department when a new drug is approved. But, the FDA will not comment publicly when a drug is rejected (Complete response letter is issued.) That information must be disseminated by the company.
There are other examples where FDA discloses information regardless of whether or not a company wants that information made public. Examples: Warning letters, Dear Doctor safety letters, updates to the Orange Book, etc.
So, you are sorta correct when you say, "Because FDA is under a strict obligation to protect such company's material information until the company CHOOSES to reveal it."
But there are exceptions.
Now, publicly traded companies must abide by U.S. securities laws, which among other things, requires prompt public disclosure of material (stock moving) information.
For any biotech company the size of NWBO, filing a BLA is a material event under any definition. If NWBO had filed a BLA, the company would have disclosed with a press release and/or an 8-k filing.
The definition of materiality often depends on the size of the company. Think about this way, if Pfizer files a BLA for a small niche product, it may not disclose because that news isn't really material to the stock.
The same cannot be said for a tiny company like NWBO. DCVax is the most important product for the company. If a BLA was filed, it would be defined as a material event and disclosed.
I can't think of a single example where any biotech company did not issue a press release or file an 8K upon filing a BLA with the FDA.
That we're actually having this debate underscores once again NWBO's dismal track record for transparency. These questions should not need to be asked. "Normal" well run biotech companies do not keep their shareholders in the dark about important developments.
