Transparency/Disclaimer: I was compensated modestly by public relations to write this article. While I have vetted each company, researched it thoroughly and I’ve done my own due diligence, my due diligence is not a substitute for your own.
Pfizer (PFE) seems to be having trouble getting its new rare disease drug approved by the FDA. As things stand, the health advisory panel that is addressing the issue has given a split vote on whether the drug, aimed at treating a rare neurodegenerative disease, should be approved.
The problem is the panel agrees that the drug does not meet the main goal of the study in treating the fatal condition in question. However, it also agrees that the drug treats a ‘surrogate endpoint’ that may correlate with the underlying treatment of the fatal disease that is the subject of the study. Basically, a decision needs to be made on whether the drug is in fact effectual at all for the treatment of the illness.
The only thing to do at present is to wait and see whether the FDA will give the drug approval. Pfizer does have other drugs waiting approval. Soon we will hear if the company’s drug tafamidis will gain approval. However, this is a minor drug in comparison to the drug mentioned above in that it has not really made as a big a splash in the news.
However, because any new drug can have an effect on pharmaceutical stocks, let’s talk about tafamidis in a little more detail. To continue reading, click here.