AcelRx Pharmaceuticals (ACRX) Completes Re-Submission Talks With FDA

AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)

AcelRx Pharmaceuticals is having a rough day in the market today after the company disclosed information with regard to recent talks with the United States Food and Drug Administration. Today, we’ll take a look at the result of the talks, how ACRX reacted to the news, and what we can expect to see moving forward. So, let’s get right to it.

AcelRx Pharmaceuticals Closes Conversations With The FDA

ACRX recently announced that the talks with the FDA surrounding the opportunity to resubmit the New Drug Application for Zalviso have come to an end. Ultimately, the FDA has come to the conclusion that it would like to see AcelRx complete another clinical study with regard to Zalviso before another New Drug Application is submitted. While AcelRx maintains their position in the belief that the results of the bench testing and Human Factors studies adequately demonstrate the modifications made to the Zalviso System and address the items raised in the CRL, and that additional clinical studies are not needed, the FDA believes otherwise. Ultimately, the Food and Drug Administration makes the final decision with regard to whether or not to approve a new drug; so, AcelRx will have no choice but to complete another study surrounding the experimental treatment.

How ACRX Reacted To The News

ACRX climbed heavily in after hours trading only to fall in a big way this morning. The bottom line is that the final result of the discussions with the Food and Drug Administration was not the result the company and its investors were looking for. Currently (11:52), ACRX is trading at $3.94 per share after a loss of 3.67% so far today.

What We Can Expect To See Moving Forward

Moving forward, ACRX has a bit of an uphill climb ahead of them. Ultimately, the company isn’t likely to give up on Zalviso, especially considering how far they’ve come with the treatment so I would imagine that we would see the commencement of yet another trial on the drug relatively soon. When this happens, the stock is likely to see gains. However, ACRX has quite a bit to prove here and, considering the FDA’s opinion, there are quite a few questions currently unanswered. With that said, I wouldn’t buy or sell the stock just yet. Investing is often a long term process; in the long run, we may see great things!

What Do You Think?

Where do you think ACRX is headed and why? Let us know in the comments below!

[Image Courtesy of Peninsula Press]

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