NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I believe there are some serious misconceptions about the normal time to approval of a drug after a trial concluded. This isn't the case with Covid-19 treatments which are being okayed without the normal formal process. Normally companies typically spend 6 months or more just in preparing the BLA or NDA that must be submitted to the regulators. On priority drugs our FDA gets 6 months to evaluate them, I'm uncertain if any foreign regulators move faster, or course faster determinations are being attempted, and sometime they occur, but figure 6 months.

It's not impossible for a regulator to act faster, perhaps without even a submission asking it to, but it's very rare. If you figure it will be a year from seeing TLD and approval, you'll rarely be surprised by approval sooner than that, and frankly it can take longer even if no regulatory delays occur. If the regulators request anything more, they get the full review time once a new submission is made that answers their request. Sadly, once that new information is received, they're perfectly free to ask another question on a subject totally unrelated to the initial question. It's sad, but in the past I've seen a drugs approval delay by a few years by totally unrelated question being asked and answered, but the drug was eventually approved. You can imagine how the stock moved based on each delay.

Gary