Here we go..new 8-K just out:

We're focusing too much on the 300 recruited versus enrolled number and missing the forest for the trees. For one thing, the PR states:

I'm reading this to mean that it's the "company" has initiated the temporary suspension of screening; therefore it is not initiated by the regulators.

Also..



It doesn't say anywhere that the company is preparing trial information "requested" by regulators.

Keeping in mind that we were expecting the first IA anytime around the June-August period, it most likely could have something to do with that. If it was a recommendation to stop for futility, the entire trial would be stopped. Remember, the company is in a cash-crunch. That could be a reason for the screening suspension, to halt further expenditures pending feedback from regulators.

In addition, looking at LG's email reply posted by Diamondjim,



And..



Why would LG be so emphatic in his words? Here too, it says that while "we" submit; doesn't say info requested by regulators.

LG ends by saying "Please stay tuned". I wouldn't use those words if something dire was happening behind the scene.

Also, keep in mind that this is a PR responding to attacks in "blogs and social media". Maybe I'm reading too much into the wording, but under the circumstances I'm pretty sure that wording has been sufficiently parsed and reviewed by the company.

However, I'm a bit puzzled by why the company would even mention the 300 recruited figure. They could have just mentioned that the trial is still on track to complete enrollment by end of year. Any thoughts on this?

If you observe closely, this is a computer-generated report, where if you specify the company name, it will automatically populate the variables in the pre-formatted text.

And that's just US revenues, right? Not counting ex-US.

Well, at least I got you to come back Pyrr :)

Ignore my reference to Prostate or other indications. The "expansion" reference was clearly related to the ongoing phase III. My bad.

Yes, I was thinking along those same lines, of a prep for label expansion. That would be super!

Regarding the lingering questions about what LP meant by "expansion", listen again to the call:
1. Minute 1:50 - "We're in the home stretch of DCVax-L phase III".
2. Followed about a minute later by "First interim analysis for efficacy expected later this year".
3. Minute 22;30 - "L will finish enrollment later this year".

Does anyone really think there will be an increase in enrollment size based on above?.

A new arm? Possible, but remote, at this late stage of the game.

A new indication for L? Possible. Here's my theory on this. They must be very confident of L for Brain. They have L for prostate sitting on the shelf for a phase III. Maybe they have found a partner. Who knows. I guess we will know in a month.

Excellent, and thank you for this. This puts to rest, at least for me, the debate about pseudo versus rapid progressors.

In the 55 information arm slide, the left column has the description "rapid progressors, pseudo progressors & insufficient doses". I presume this applies to the SOC column too; not just for the DCVax-L column. So I take it that the 8 - 11 months improvement over SOC still stands valid. The references you included seem to indicate that roughly 20% of the rapid progressor population "could" be pseudos but very difficult to determine precisely. The new information in the slide seem to suggest that the median could be around 20 months and comparable to the 18 months suggested in the slide. This is comforting while we await more details.

That's my view too. Five case studies out of 40 is 12.5%. I would like to see more. Moreover, LP did say that she has been advised against revealing too much and I can understand that too. It would make a bigger impact if all the results were announced in more formal setting such as ASCO which would lend more ligitamacy. But until then, the valuation will linger. But not announcing phase 1 data would provide more ammo to the shorts. I expect that it is most likely scheduled for ACSO. But as Pyrr pointed out, phase 2 results will be the most anticipated.

Also, DCVax-L is still up in the air. There is certainly some comfort for longs due to HE in Germany. The fact that we are building manufacturing in UK is definitely an indication of LP's confidence. But it will not be a contributor to share price until we have some results. I personally hope that they don't decide to stop at interim, even if that is a recommendation of the DMC. Having been a DNDN investor may have something to do that. For those of you who may have followed DNDN in the past years, you may recall that DNDN was sent back to do another phase 3 despite an ADCOM vote of something like 27-3 for safety and efficacy. (Arguments were small size of trial, limited efficacy, cross-overs, etc). If you recall, Howard Scher, who then was the chief clinical investigator for Zytiga, which was still in trials, wrote a letter to then FDA's chairman von Eschenbach against the approval of Provenge. The head of oncology at FDA, Pazdur, was seen passing notes to Maha Hussein who was in the advisory panel who was one of the no votes on efficacy on the ADCOM. Michael Milken (remember him) who set up the Prostate Cancer Foundation and was believed to be a supporter of Zytiga was a friend of von Eschenbach. So I still worry about the larger forces that could impede little NW's progress. I'm more concerned since they are so many big players involved with CI and would love to see NW's delay. I hope the FDA is a cleaner organization now. (Sorry for the rant about DNDN).

By the way, I don;t care a hoot if NWBO has a CFO now or not. Right now it's mostly book-keeping. We do undergo external audits and a formal audit opinion is issued. Auditors do look at related party transactions and whether they are at arms-length. If we were in China or India, then external audits may not carry much weight, but I'm reassured that's this is the US. (Don't beat me on this please. I'm speaking relatively). I live in another country, but I would never buy individual stocks outside the US). We are not generating revenues yet and my opinion is that LP is taking us along on hand-to-mouth, or just-in-time-financing :). That's a another confidence booster for me, because she is expecting share-price to rise in the near future when a secondary will be more productive.

The fact that LP has resisted partnership is also a good sign. Why would one want to partner when one is feeling confident about success? If LP was a scam artist, she would take the money and run. Notwithstanding, I defintely like the idea of combo-partnering with a CI candidate. We need to be in this game while outcomes are still uncertain.

Pyrr has outlined a strategy for us and I fully agree. The only thing I would add is that, never go into a binary event without being partially or fully hedged. This is bio-tech. I'm long and watching closely :)

Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 574 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.9% (5/574) of patients receiving OPDIVO; no cases occurred in Trial 1. In Trial 1, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; one with Grade 3 and five with Grade 2. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.

About JUNO...did anyone notice that the management team is loaded with Dendreon alumni? Hans Bishop (CEO), Frohlich (R&D), and Smith. Interesting.