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longusa

03/19/15 2:35 PM

#31153 RE: Pyrrhonian #31093

Hi Pyrr, thanks for the Recist 1.1 summary. I was generally aware, but did not realize the 5 tumor aspect.

Curious then that the apparent PhII protocol will be for only 3 tumors. It would seem (IMO) that NW would be wise to either change the protocol to at least 5 tumors injected, or use an inclusion criteria of only 3 measurable tumors allowed in. Perhaps we have not yet seen the final protocol.

longusa

03/19/15 2:39 PM

#31155 RE: Pyrrhonian #31093

BTW, Note the DCVax-L rGBM AACR Abstract (Liau, Prins, Bosch et al) uses Rano criteria. Perhaps due to the Recist issues discussed over the last several days.

RRRichmond

03/19/15 9:12 PM

#31182 RE: Pyrrhonian #31093

I am in agreement with Pyrr. The Direct Phase 1 looks very promissing, (but unless the ORR is there I do not see a path to AA.) The FDA could reinvent its criteria, an evolutionary change is possible, not a revolutionary change. The point he made regarding the probability that Direct will not show meaningful Recist 1.1 results leaves the stock wide open to attack from AF and others as they publicly analyze the results based on existing criteria. There is little defense against such analysis and it certainly will come. This is one possibility where our recent gains could be pushed back to the high 5's. Betting that the company has been "pocketing" substantial, measurable, criteria-based, positive results, and will now announce them, seems a weak bet.

The other scenario that would put us back in the 5's is if the DCVax-L trial were to receive anything less than a stop for stat sig results at the long delayed, first interim. This interim could be reached at anytime. We have all touted DCVax as a mega treatment in the making. If there is a tear in Superman's suit, watch for the fallout.

Pyrr's advice to protect the downside of your position with Puts, at the cost of surrendering the next dollar of gain is a sound thesis in that the serious longs he was addressing could care less about the next dollar's gain. We're longs for gains well beyond that point, but a drop back to the five's could really suck the air out of this stock until the second interim.

Pyrr- if your reading this, may I ask how far out are you going with these Puts?