With a couple of weeks of prep time, and probably several re-submissions and calls for clarification. I'm sure they have the legal translators on call, but it takes time to make sure you've got it just right, and in legal and technical documents, a single word (or even a single umlaut) can completely change the sense of a passage. My company sells equipment in Germany, but our contracts are in English. We can be certain that it's a week or two between sending out the contract and getting the signed version back for exactly this reason.
They got the original on the 21st. It took a week to get a translation (not unreasonable for something that needs to be manually translated by someone who specializes in legal/medical translation, not a common specialty). That takes it to the 28th. Figure it took another 3 business days to confirm certain aspects of the translation, that takes it to the 5th. They submit it to their newly hired and approved Information officer on the 6th, get the approval at end of business (Germany) on the 7th, and release it on Monday the 10th. This was not months and months. It was two weeks to translate, clarify, and get approval on a lengthy technical document.
See their answer today. I pretty much called it dead on, no delay, they released it as soon as they were certain of their translation and had the approvals needed from German regulation.
Have you ever worked in Germany, or with a German company? I have, and fortunately for people like you, most Germans, especially in technical roles, speak good to excellent English. And even then, given the time difference between the east coast and Germany, you've got time for one phone call or a couple of back and forth e-mails between when the US comes in in the morning and the Germans go home at night. To translate a multi-page technical document, make sure that all of the translation is correct, both in wording and in legal implication, is hardly as simple as running it through google translate. I expect several multilingual lawyers on both sides of the Atlantic were working very long hours to get it done in a week.
Except they didn't, they released it as soon as they were clear on what they had, and had satisfied German regulatory requirements to do so.
You do realize that "today's" post was simply an additional publisher waiting until today to publish the press release, and not something that NWBO had control over?
And as to why they might have waited a bit to print good news, the most likely answer is that they were making sure they understood all the ramifications. The German regulatory system is not exactly simple, and understanding exactly what this authorization meant could easily eat up that much time. Remember that this company was bitten once already when they issued a press release that gave the wrong impression of what a European authorization meant. And that's far from the only possible answer, it just seems to be the most likely one to me.
Based on what was it, 16 people? Yes, the numbers look good, but there is a reason drugs aren't based on a single, small, unblinded, no control-arm study. I wouldn't be here and invested if I didn't like those numbers, but they are not definitive.
I don't think production for this treatment is really something that ramps up in the way a traditional manufacturing line would. Since it's a personalized treatment, mass production essentially means more of the current approach, with, maybe a few economies of scale.
Yes that means hiring and training more techs, which can be slow, especially in Europe, but it shouldn't be critical.
Also we're a long way from actually getting those 3500 patients. Approval for use is not the same as acceptance by doctors.
A hunch, the PI trial, the fact that it can't really do much harm, prior poorly reported compassionate use cases? I don't know, I just know it can't be based of the PIII trial, since that's information they don't have.
Oh, I agree on that, I just want to be clear on what it does and doesn't mean. It's still possible (I think it's unlikely, but possible) that the trial is a failure.
Please get your facts straight. The trials in Germany are just getting started, and would remain blind even if they weren't.
At most, they only thing from this current trial driving this decision is the safety continue. If it's safe, and it might help, that might push them to let people (whose prognosis is otherwise not very good) try it. Otherwise, this decision has to be based on information already available to the public.
I've always thought it was a possibility, but I'm not going to say I think it's much more of one. This German (short term) approval is a wonderful thing, but it's not based on any significant new information, since they simply don't have access to that.
Even if the treatment is effective, the chance of being able to show that with a statistical significance at this point is not extremely high.
To be clear, I am still in, and long, and I love our chances, but I try not to let enthusiasm get the better of me.
Two weeks ago, it went to 7+ on no news, and then fell back down on no news. This one has a bit more weight behind it. Also, if they can get the German program up and running fast enough, it may go a long way towards reducing their need to do a secondary at all.
Given that it's written, it would be libel only. And given that it's an opinion piece, it's protected speech.
I fully believe the guy is either deliberately or at least with willful blindness interpreting the facts as negatively as possible, but let's be careful. Free speech is an important right, and someone being a jacka** is not sufficient reason to abridge it.
They expect enrollment to be completed by September this year. That came out a few months ago, and would be a pretty clear statement on the current enrollment status.
What possible bad news? At this point safety is out of the way, so there are only three possible outcomes. Halt for futility, halt for efficacy, or continue.
If the treatment isn't actively killing people (the safety bit), a halt for futility is unlikely this early in the trial, since they would have to confirm statistical equivalence which is extremely unlikely without the complete trial. Therefore, the worst probably new would be a continue, which is generally a good thing. The possibility of a halt for efficacy is still there, if small.
Ah. I was apparently seeing several incomplete reports that only mentioned the continue on safety, not the pending efficacy.