Replies to post #380535 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

King,

I'm not a fan of the FDA at all. I believe if a drug developer develops a drug to be a monotherapy, fine, test it that way, but if they always intended the drug to be used with other therapeutics, that's how it should be tried. The FDA likes to run Phase 1's that are monotherapies, even when the product isn't intended to be used that way. I understand they're emphasis on safety, but if the combination of drugs they want to use their product with is already SOC, the safety profile is known, why not add the experimental product.

What the FDA does adds tremendously to the cost of trials as monotherapy trials are done as Phase 1/2 and if safe, but not effective enough for consideration of approval, they essentially repeat the trials in combinations which they wished to use in the first place. The time and money spent is foolish if all the preclinical work the company has done demonstrates that for efficacy it should be combined with other products.

I know medical professionals will disagree with me, they like the cautious approach taken by the regulators. I'm of the belief that historical data is adequate for comparison, and all who volunteer for a trial should get the experimental treatment.

I believe the control in our trial was worthless, with all but about 30 crossing over I believe we'll find that those who didn't cross over died to early to do so. Some who crossed over are probably among the living, but more may have been had they received the vaccine up front. All sorts of K-M plots can be developed from the trial, I don't think it will matter how you look at the data, people will be living longer, and some people may be considered cancer free. It's sad to me that such a trial takes well over a decade. I suspect that after 5 years the clinicians could have said we're seeing something that looks very good. Why not approve it and conduct a giant Phase 4 Trial where every time it's used, including all off label uses are included.

I believe that if we want to bring down the cost of medicine, you start with cutting the costs involved in gaining the approval of new drugs. I agree with knowing a drug is safe, but after that less time and money should be spent proving it's better than others as long as it's been shown to have some benefits. A drug that only benefits say 10% of the target population, but is the only one that does, is awfully important if you're a member of that target class. In most cases, I think such a drug would fail in trials.

Gary

[exwannabe]

Thank you for your sharing. I do have a large amount of shares. But after watching Dr Liau’s latest presentation especially at the conclusion slide she said “it is difficult to do single agent trial to show efficacy” which kind of threw me off there. What’s your thoughts?

There is a simple reason why it is getting harder for mono agents to prove effective in many or most settings.

We do have "effective" agents in cancer. Yes, there are many that are not cures, but that does not change the fact they work. Unless some new agent is a true cure, it is often going to work better combined with agents that also are effective.

Look at DCVax-L as an example. It has never been trialed as a single agent in nGBM. It is used, following surgery and chemo-rad, in combination with tez. And in her most recent comments on the subject she is suggesting a quad combination as "the answer".

[marzan]

Did you not see senti's km chart that she drew the 2018 JTM data on top of the contemporaneous SOCs that outperforms SOCs by Leaps & Bounds?? This is the Primary Endpoint accepted by UK and Germany which is literally shown to be met by the single agent DcVaxL. What more you want? LL is saying a single agent is not a cure for all molecular profile patients. She is implying combo treatment in those hard to cure patients. Did you know in every combination of her combo research, DcVaxL is indispensable and the other drugs including PD-1s like Keytrudas are adjuvants?? Stop being smart soft bashing; we know what you are doing.

[erik007tc]

For someone who has a large number of shares you don’t know Sheyt!

[VuBru]

King -- Someone posted an interview with LL not long ago here in which she pretty much explained the source of this comment. Her point was that GBM was such a heterogeneous disease that it was unlikely any single intervention would work fully for all patients. She stated that for an intervention that was actually effective, efficacy in certain subgroups would be expected. For DCVAX, I assume she is thinking that it works particularly well for methylated patients (based on blinded data published previously). These same data suggest that it may also work to some degree (but not as well) in unmethylated patients. That seems to capture her comment in a nutshell.