Diffusion Pharmaceuticals (DFFN) Stock Runs On Accelerated Review

Diffusion Pharmaceuticals DFFN Stock News

Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) is having a great start to the trading session this morning, and for good reason. The company announced that the United States FDA will accelerate the review of its COVID-19 treatment candidate. Here’s what’s happening:

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DFFN Stock Pops On FDA Accelerated Review

In the press release, Diffusion Pharmaceuticals said that the FDA will accelerate the review of its clinical development plan using TSC in COVID-19 patients. In particular, the treatment would be provided to patients experiencing severe respiratory symptoms and low oxygen levels.

In COVID-19 patients, a lack of sufficent oxygen levels can lead to the failure of vital organce. It is believed that TSC will improve oxygen levels in these patients, ultimately leading to better clinical outcomes.

In a statement, David Kalergis, CEO at DFFN, had the following to offer:

This news of accelerated FDA review of the proposed clinical development plan for our lead compound TSC in a COVID-19 ARDS program is most welcome. We continue to work with hospital and regulatory authorities in the U.S., and now also in Eastern Europe, to forge the fastest possible pathway to approval for TSC in the treatment of COVID-19 patients.

Why This News Is So Exciting

First and foremost, we all know that the COVID-19 pandemic is a real issue. It is changing life as we know it, and nobody really knows how long it will last. One thing that we do know is that if we want to get the pandemic under control, we’re going to need positive treatment options. That’s where DFFN comes in.

If all goes well, the TSC therapy by Diffusion Pharmaceuticals will lead to better lung function, improved oxygen intake and ultimately, better outcomes for COVID-19 patients. Now, we’re going to see movement happen very fast.

In general, the FDA has up to 60 days from the submission to respond. However, the FDA said that it intends on significantly shortening this review time for TSC under its Coronavirus Treatment Accelerated Program, or CTAP.

With the expectation that the treatment will move to the clinic shortly, the company is already prepping clinical sites, and with the drastic need for a treatment, development is likely to happen very quickly. As such, we can expect to see several catalysts in the near future from DFFN, making the stock hard to ignore.

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