Replies to post #748044 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I agree and I believe that LP has it planned. I'm as frustrated as anyone here, but I don't blame the company, I mostly blame the regulators as a whole, though the UK is the primary concern here.

To me no new product should take one or two decades from genesis to approval, but most of them do. I'm not saying extreme care shouldn't be taken with meds for headache's, colds, etc. but when it comes to deadly disease like cancer, and especially the deadliest of them like GBM, shouldn't take the time this is taking. Likewise the equipment to make them shouldn't take years to approve. I'm all for the use of Phase 4 trials that verify benefits by tracking all who take a product. I'd be fine with an EUA prior to full approval, allowing patients to pay, and use the product while final approval is coming, I also am fine with confirming trials, as long as the products approved, is being sold and covered by insurance, that way the costs of the trials are easily handled by the sales.

My point is, approval of products intended for the most deadly and debilitating diseases could be advanced far faster with confirmation coming after they became available. I believe people like Dr. Liau knew the benefits of DCVax-L were dramatic a decade or more ago, why couldn't the regulators get that picture, issue an EUA allowing the sale, instead of 1.7 million pages they could have received feedback from tens of thousands of patients who received the vaccine in the decade. All I'm saying is instead of looking at 1.7 million pages they could have the data from tens of thousands of patients. We know the majority of these people would be dead, but I believe it would be clear that they'd have lived much longer than had they been on the SOC, which they had data for. Not only that, when Dr. Liau and her staff learned the benefits of Poly-ICLC it could have been added and benefit increased dramatically.

Of course NWBO would have had difficulty meeting demands until they discovered FlaskWorks, but perhaps it would have been found far sooner and allowed to be used far quicker if an EUA was applied to it as well. If patients are benefitting from its use, what further proof is needed of its effectiveness.

My point is that, if the time required to put life saving products in use is reduced to half of less of what it's taking today, why not do so and track the benefits. If the benefits aren't there the treatment can be removed

[dmb2]

Completely understand and agree, I just shake my head, take a breath and envision a tush push from the 1 yd line for approval in March. We seem to get penalized a lot and just keep moving forward play after play.

GLTA

[StonkMaster]

In all fairness, an approval in mid-end March is still in line with assessment timelines over the past year or so. I've always thought that the clock started on the 2nd validation date of March 7, 2024, so if we get approval let's say March 27, 2025, that would be 385 days. Subtract the standard 60 day clock-off and we're at 325 clock-on days - which is just over the average. I guess once you add in the inspection delay you're right there in line with everyone else.

Not saying this is good - just saying it's not out of the ordinary.

[Doc logic]

DJPele,

Anyone who gets this much time to prepare and is as talented as Linda Powers is either ready or needs to be replaced. She is ready and it’s the bash crew whose time will be up; ). Best wishes.