We examined many explanations about the rallying in the biotech stocks, including the reports stating that the President’s threatening of a crackdown on pricing may have been misinterpreted. A more convincing possibility was the feeling that the newly appointed FDA commissioner, Scott Gottlieb, might have managed to show that he came to bring about a change in the way the FDA tasks have been conducted in the past 50 years or more. The changes are mostly based on the big advancements made in understanding the vehicles of life, especially the human body at the molecular level.
Dr. Gottlieb’s discussion at a Senate subcommittee was mostly about a tremendous change in the agency he was called to lead, including equipping the agency with what would facilitate the speedy development of next-generation therapies, particularly targeted drugs that treat patients with rare diseases or molecularly-defined cancers. The discussion at the Congress was about lowering healthcare cost without hurting the industry. Dr. Gottlieb stated that the FDA plans to facilitate pinpointing the drugs that promise to fill unmet needs with what’s needed. Suggested strategies include improving clinical trial designs and modernizing the tools that enable better evaluation of treatments’ safety and efficacy.
Of the new FDA commissioner’s priorities is creating guidance on the clinical evaluation of targeted therapies for rare diseases. The goal is to simplify and facilitate the development of drugs aimed at rare genetic disorders and diseases that share a similar genetic fingerprint, even if they manifest in slightly different clinical expression.
In a different article that we will soon publish on the new Prohost website, we will discuss more fully the new strategies the new FDA Commissioner is bringing to the table. We will see what Dr. Gottlieb promised to accomplish with regard to improving medical treatments, facilitating the task of creative scientists and helping the drug developers put as quickly as possible their breakthrough life-saving products in the hands of the medical specialists.
Finding Firms that Fit the FDA Ambitious Plans
Facilitating the development of targeted drugs that aim at treating rare genetic disorders and a multitude of diseases that share a similar genetic fingerprint motivates us to find out the drug developing firms that have what could provide the described promises. These are the firms that have the technological capabilities and products that promise bringing breakthrough treatments for rare diseases, genetic-derived diseases and malignant diseases, which need to be encouraged rather than strained by rules and regulations based on outdated information.
Do firms that fit this description exist?
The answer is yes of course they do exist and we wrote a lot about them. As a matter of fact some of them are old and many of them are new members in the Prohost Portfolio. We will name them first and then post a comprehensive study on each under a new section at the new Prohost website.
We wish that you become familiar with using the new Prohost website as quickly as possible. We will do everything possible to enable you to use it to its utmost benefit.
Enjoy your weekend.
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