I'm in line with Doc logic on this. After carefully rereading the PR, I strongly believe they left themselves two options in this regard.
1. Data lock for PFS first then OS data lock several months later, or
2. Data lock for PFS must wait for OS data lock.
I'm currently trying to read a great deal of information on data locks regarding secondary and confirmatory endpoints. Because use of the same trial for confirmation is less common, I am having trouble finding examples on that, but what I can tell you so far is that confirmatory endpoint data locks are also taken very seriously by the EMA and the FDA.
You must remember, the company is completely blinded to the results. In fact, like the "Inhance" trial, they were probably blinded to the interim analyses (if they were actually carried out) as well.
So in this situation, I have no doubt whatsoever that they rely heavily upon regulator guidance based upon the FDA Czar's relatively recent comments regarding how the FDA now handles these types of matters. Like a couple other posters, I do not believe this orphan designated trial is blinded to specific regulators.
People constantly forget to mention PFS is likely a surrogate endpoint that was designed to allow earlier approval. Whether this trial and/or the recurrent trial are used for confirmation has likely not been determined yet. However, I strongly believe that the surrogate endpoint (PFS) will be used for AA, and the regulators will keep OS blinded in this trial until 233 OS events occur. The reason they can do this in my opinion is that everyone has already crossed over from the placebo group (imho) -- a most unusual piece of knowledge to have, but very understandable to justify the ethics of not unblinding the trial early to cross everyone over to treatment -- which is usually what would happen.
Rememeber, they are speaking to patients, regulators and investors when they release their PRs, they would not want to take options off the table prematurely just to soothe my investor fatigue, but that does not mean they have no sense of urgency. Upon more reflection, even the exact month 248 occurred is subject to flux due to possible near term or follow up image interpretation modifications, so instead, they give us a three month window.
I think Les is more in the dark than most people think. There are very good reasons to keep management blinded from the trial, and even blinded from IAs. It allows more flexibility later in the trial for regulators.
In the end, this is an orphan designation, and a small pilot trial already demonstrated this therapy can potentially significantly help children as well. Brain cancer is the leading cause of cancer deaths in children. There are memorials at a school nearby me for a child that died of this disease. He did not live long enough to experience his first kiss, marriage, children and the rest of what our lives have to offer.
Regulators, Biden, Trump and many others all understand this. If you want to complain about the pace of this trial, I'd try appealing to them; but my guess is they already know and are moving mountains to avoid additional memorials here and abroad.
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