Fibrocell Science Inc (NASDAQ: FCSC)
Fibrocell Science had an incredible day in the market yesterday. However, today, the stock is taking a bit of a dip. Since the opening bell, the stock has been teetering near the break-even point, spending most of the day in the red. While this may be concerning to some, to me, it’s an opportunity. At the end of the day, Fast Track designation was announced just yesterday. Below, we’ll talk about the news and what investors should be watching for ahead.
The Big News On FCSC
As mentioned above, yesterday proved to be a big day for Fibrocell Sciences. The company made a big announcement surrounding its flagship candidate. So, what was the announcement?
The United States Food and Drug Administration as granted the company Fast Track Designation for the FCSC candidate known as FCX-007. FCX-007 is a clinical-stage candidate that is being tested for the treatment of Recessive Dystrophic Epidermolysis Bullosa, also known as RDEB. RDEB is arare genetic skin disease that proves to be devastating among patients and has no FDA approved therapies. In a statement, John Maslowski, CEO at FCSC had the following to offer with regard to the news…
“Fast Track Designation represents a significant milestone in advancing clinical development of FCX-007 for the treatment of RDEB… We are pleased the Agency has awarded this designation to FCX-007 which, we believe, has the potential to be the first gene therapy to treat the underlying cause of RDEB and to bring relief to patients suffering from this debilitating, painful disease.”
What Does Fast Track Designation Mean?
While we know that Fibrocell Science has achieved Fast Track designation, many stories tend to leave out just what that means. So, what does it mean for the company? Well, the truth is that there are various benefits involved. Those of most importance include…
FDA Meetings – As a result of the Fast Track designation, FCSC is now entitled to more frequent meetings with the FDA. In these meetings, the company and agency will discuss the drug’s development plan. Because these meetings are more frequent, the time it takes to get from this point to FDA review will be a bit faster.
Faster Reviews And Approval – Another benefit here is that the FDA wants to help get this approved faster than usual. With no other treatments available, it makes sense. So, if the criteria are met, FCSC could benefit from Accelerated Approval or Priority Review.
Rolling Review – Finally, as a result of the Fast Track designation, FCSC can now send FCX-007 through a rolling review. This means that the company will be able to submit completed sections of its BLA to the FDA. Without the designation, the company would have to wait until every section of the BLA was completed before submitting the application as a whole.
What Investors Should Be Watching For Ahead
Now that the FDA has granted Fast Track designation, Fibrocell Sciences is likely to hit the ground running. That means that we’re likely to see big news often here. Watch for news surrounding FCX-007. Anything that breaks is likely to present an opportunity!
What Do You Think?
Where do you think FCSC is headed moving forward? Join the discussion in the comments below!