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notbrad

01/18/15 9:33 AM

#28399 RE: staccani #28398

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 :)


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Rkmatters

01/18/15 10:51 AM

#28402 RE: staccani #28398

My view is Ph I results will continue to impress, but it is a given that they will need to inject multiple tumors to see if they can evoke an immune memory response. Also I expect that one injection site has not been enough to result in complete eradication (which LP imo made clear to us not to expect when she discussed the ovarian pt case study's new small nearby tumor). That said, it's clear to me that one tumor injection has extended survival, and continues to reveal Direct treatment is both promising and effective.

They shared 7 case studies thus far (two in Sept; three in Nov; two in December). From the 7 case studies they've shared, we have yet to hear of the 3 pts to which they reported in June, that had no live tumor cells in their primary tumor so there should be more good news ahead (unless the 3 "no live tumor cell" pts were among these 7 pts but I don't remember that highlight mention in any of the reported studies).

We've also seen an MDA abstract which states they're seeing both local and systemic effect in majority of pts (more than 51!). So again in my opinion, efficacy is being seen and will only get better in Ph II, once they're able to get to apply lessons learned from first phase on optimal maturation, dosing and injection schedule. After all with this Ph I only one tumor has been injected, with a spaced apart schedule (closer is better), with not always the optimal DC maturation, but yet they're seeing local with some systemic effect; so yes, I imagine Ph II will be miraculous as far as extending OS. Plus LP was still able to state back at the Oppenheimer Dec conference, "stay tune for the end of the trial, but they're seeing encouraging survival."
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H2R

01/19/15 11:32 AM

#28408 RE: staccani #28398

Hello Staccani,

Last year, LP started to share early results and NWBO got slapped pretty bad by MDA's Buzdar (or is it Buzzard) & theStreet's scribbler (AF) for not waiting until the end of the phase before the PR's.

Buzdar has nothing to do with this trial, has his own competing trials around breast cancer, and has published himself early results, but bad faith does not mind those small matters of conflict of interest. AF did his best to paint both the Company and LP in the worst possible terms.

This was a very big deal in 2014 and it helped the shorts & keep the PPS down.

IMHO she says as much as she can, but not more.

Long NWBO!

Since I do not think that LP would be so masochistic to conceal astounding esults, I think that is because there is some evidence of local and sistemic efficacy, but because the doses, frequency and injection into just one tumor (as opposed to all tumors) are not optimal, then the results are not representative of how good they could be in terms of efficacy.