Adam Feuerstein has just published his seventh or eighth or ninth negative blog on Northwest Biotherapeutics in the last month. I am losing count. It carries the alarming headline "Northwest Bio Warns FDA May Throw Out Phase III Brain Cancer Study". In this article as in previous ones, he has presented a speculative theory that is just that, his speculative theory. His headlines are misleading in that he attempts to attribute statements to management that were never made. I am getting tired of writing responses, but the extremely serious claims and accusations that he makes can't go unanswered.
This latest article relates to the risk factors section in the 10-K. As everyone knows, lawyers write risk factors that try to cover any possible event. I remember one that recently warned that the Company's production facility which was in a west coast city was at risk of being destroyed by a tsunami. Lawyers get paid a lot of money to include all plausible and some implausible risk factors they can think of and they continually add to the language in risk factors paragraphs. After reading the risk factors section of most companies, one wonders why anyone would ever want to buy a stock.
Feuerstein singles out and attempts to sensationalize one risk factor in the 2013 10-K. He wrongly states that the Company "snuck a brand new risk nugget about the brain cancer vaccine DCVax into its annual report filed with the Securities and Exchange Commission on Tuesday". This is clearly wrong as the exact same language was included in a prospectus for a successful equity offering in November 2013 which raised $27 million. It was not snuck into the 2013 10-K; it has been in the public domain for some time.
At the heart of the Feuerstein argument is that the FDA will not accept progression free survival as the primary endpoint of the phase 3 trial for DCVax-L. I think that he is not aware that progression free survival and overall survival correlate very well in judging the efficacy of a new drug in an an aggressive cancer like glioblastoma multiforme. In this article, I provide some persuasive documentation that progression free survival is an excellent primary endpoint for this phase 3 trial. I urge you to read my arguments that appear toward the end of this note.
My bottom line on this latest Feuerstein blog is that it presents no new information in regard to whether the phase 3 trial will be successful and if the FDA will then approve the drug on the basis of a successful trial. This belies the headline of his blog which to repeat says "Northwest Bio Warns FDA May Throw Out Phase III Brain Cancer Study".
The full article can be accessed on my website at this link:
Disclosure: I am long NWBO.