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iwasadiver

12/31/15 10:21 AM

#49272 RE: beartrap12 #49271

I agree with you. I've been reading between the lines for the past 4 months and I truly think people are misreading the hints. I believe Linda Powers is as savvy as they come and is doing things in a way not done before. This is unsettling to those who rely on the norm to make them feel confident in their investment. I've asked people to read Linda Powers' resume on Bloomberg and think about the moves she's made that are being reviled by those who can see nothing but crookedness in offbeat and clever moves.

If I'm wrong I'll be very surprised, but I think I'm very right. I've watched her work for over 8 years and I'm impressed.
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Sojourner55

12/31/15 10:21 AM

#49273 RE: beartrap12 #49271

LP's focus is getting this approved and to market and I don't think she is fazed with the day to day SP. I remember when Facebook went public and the stock tanked to around $17, all the naysayers were out criticizing the company but the CEO was focusing on the product and see where it is now three years later. L and Direct has the potential to be game changers for cancer and the potential is enormous. This is why it is being viciously attacked. Those who put out the red herring that LP is siphoning off funds to Cognate misses the point that she has more to gain when the SP explodes instead of the "measly" coupe of hundred millions or so claimed. As she said, go big or go home.
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OutsideLane

12/31/15 10:42 AM

#49277 RE: beartrap12 #49271

Thank you for going through the in depth analysis. I don't know that your numbers were as convincing as you proposed. We simply don't know. We don't know when the IA was triggered, if it has been triggered. We also don't know the mPFS or survival curve of the placebo arm of the study. You mentioned that the UCLA study said it was 8.1 months, but that wasn't a controlled study. In fact, they didn't tell us anything specific about the comparison population.

Here are some factors that I think will make comparisons or analysis difficult.
1. The study is only accepting patients with KPS of 70 or above. Historically available information about survival of GBM don't show anything about how patients in this population survive, but one can assume that they survive longer than the typically published mPFS.

2. Patients in this study were excluded from the treatment arm if they had tumor regrowth etc between randomization and first treatment. Many of these patients landed in the information arm, but many simply stopped treatment. Note that published numbers for mPFS would include those patients, and the fact that they are excluded means the mPFS for this study should be higher.

3. Patients in this study in the placebo arm were allowed to crossover to the treatment arm if the progressed early. If they switched, and the vaccine works for them that could result in a progression event, but it isn't clear to me from the trial design it would.

4. We simply don't know the ages of the people recruited into the study, or how they were randomized into different groups. While GBM usually occurs mostly in older patients, a younger group in this study would result in longer mPFS since age has been shown to be inversely related to survival. Any imbalance in how patients are randomized between the two arms would further change this effect.

In the end, it is simply better to just wait with bated breath.
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StockFollower

12/31/15 1:52 PM

#49305 RE: beartrap12 #49271

Great reminder! Your conservative numbers are impressive. Top that with a first quarter Direct enrollment and 2016 could be a game changing year for overcoming cancer.