SAP was revised before unblinding, and the issues were resolved. They may ultimately and certainly will discuss all the relevant details, by the at the end of the day, given other precedents and this particular case and changes to policies, I believe that 1) this is an orphan indication; 2) a serious and deadly disease for which progress is much needed and has been long coming; 3) it has immense and broad support from patients, non-profit brain tumor orgs and the doctors that treat patients in this area; and 4) it has delivered undeniable survival benefits to patients and to the bottom line costs of care as well (and can be delivered in a doctors office) as, and this is extremely important, it has limited to no side effects.
They will certainly weigh all the issues thoroughly, as they always do with every drug and the previously approved drugs also has issues and challenges. But at the end of the day, there will, in my opinion, be an enthusiastic regulatory approval.
IMHO, this is a serious breakthrough and looks to offer immense benefits to expanding combination therapies that very possibly will rush what many expect to be potential cures to a larger and larger proportion of patients who may have many different tumors and cancer types. Additionally, dendritic cells have promising other potential uses beyond oncology.
This will be a huge new area of research and a new tool set with which to work. I do not believe that regulators will likely say no.
But yeah, they will discuss all of it including criticisms. That’s their job. But they won’t make up facts or stories about the trial to advance nonsense claims about why it must be rejected. That, I am confident, will not happen.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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