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Yesterday I published an interview that took place between me and one of the leading medical doctors in the treatment of breast cancer, Dr. George Peoples. The interview looked at the current state of breast cancer treatments along with his view on the clinical trials of NeuVax. The only problem was that the interview was conducted last week, therefore not answering a lot of the questions that investors have been asking as of late.

As a physician, Dr. Peoples deals with the scientific aspect of NeuVax. As for the logistics and final decisions of the trials, Dr. Mark Ahn, Galena Biopharma's (NASDAQ:GALE) CEO, is the best person to talk to regarding any investor concerns. Therefore, I decided to take it upon myself to contact the company's CEO and although he only had five minutes of free time, he was forthcoming about the questions that I asked. The goal was to address any immediate concerns and allow investors to make an educated decision without being influenced by speculation or the opinions of others or myself.

The first question I wanted to ask was about the data presented in December and the data to be presented at this year's ASCO. At first glance it may appear as the same study, but with different data. Therefore, I wanted to know why it had become so confusing. He responded by saying:

Dr. Ahn

The confusion appears to be a result of combining two different Phase 2 trials: SN 33 (Node Positive) and SN-34 (Node Negative). (You may find additional clarification at here.)

Brian Nichols

Next, I wanted to clarify a few questions referring to DFS being the inverse of recurrence rates and landmark analysis.

Dr. Ahn

DFS is an estimate until the final patient has completed the trial. The trial is ongoing as we state and represent by giving a median follow-up; therefore, the DFS does not represent landmark analysis.

Brian Nichols

But shouldn't the DFS decrease with time?

Dr. Ahn

No, the DFS is an estimate, as patients progress through the follow-up, the actual denominator at a given time point increases. If the number or recurrences stays constant and the denominator increases, the DFS will increase not decrease.

Brian Nichols

Some have insinuated that the Phase II trial was actually negative, or that the results (p>0.08) were a result of cherry picking data, and that the control group was less healthy and treated with less Herceptin. How would you respond to these comments or beliefs?

Dr. Ahn

While the purist will argue that p><0.05 is sacred, the realist understands that the chances that the Phase 2 study was positive may not have been 95%, but was 92%. The p><0.08 analysis of the primary endpoint was for the entire 187 patient trial, not a subset or based on cherry picking. And if we're looking at absolutes the only disease characteristic that did reach statistical difference, ER-/PR-, was worse in the vaccine arm, which tends to be forgotten.

Brian Nichols

Did Herceptin reach statistical difference?

Dr. Ahn

Herceptin did not reach statistical difference in this particular trial either. However, 11% of vaccine patients were treated with Herceptin which is known to decrease the risk of recurrence by half in these particular patients. So, at the most Herceptin treatment could only account for 5.5% of the entire reduction in recurrences seen in the entire trial.

Brian Nichols

I appreciate you taking the time to speak with me on such short notice, it has been a real pleasure. I wish the best for you and Galena BioPharma at trying to cure such a deadly disease.

Source: A Short Interview With Galena CEO Dr. Ahn To Address Recent Concerns

Additional disclosure: The transcript of the interview has been edited for length, grammar, clarity, readability and syntax. It is not to be used to make any investment decisions but rather informational purposes only.