Maryland-based pharmaceutical company Novavax (NASDAQ:NVAX) is a Wall Street disappointment right now. NVAX stock is down more than 40% so far this year. But that doesn’t tell the full story of the stock’s slide.

It was less than a year ago that NVAX stock traded for a hair under $330 per share. The company was a late entrant into the race for a Covid-19 vaccination. But there was optimism that its shot would win regulatory approval around the globe.

Nearly 12 months later, where are we?

True, NVAX won Emergency Use Authorizations to distribute its vaccine in more than 30 countries so far.  The most recent country to sign on is Australia, which on Jan. 19 granted approval for the company’s branded Nuvaxovid shot.

The European Commission gave its authorization to Novavax in December. And the European Union signed an advanced purchase agreement for NVAX to supply 200 million doses of its vaccine.

But Novavax is still shut out of the U.S. market as vaccines are provided by Pfizer (NYSE:PFE), Moderna (NASDAQ:MRNA) and Johnson & Johnson (NYSE:JNJ). Its failure to overcome manufacturing issues pushed Novavax behind its rivals in the vaccine race.

That could change soon.

An Important Milestone

On Dec. 31, Novavax announced that it finally completed its data submission to the U.S. Food and Drug Administration. That clears the way for it to apply for an Emergency Use Authorization from the U.S. one month later. That’s just a few days from this writing.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” CEO Stanley Erck said.

“We thank the U.S. Government for its ongoing support of our COVID-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine.”

Winning authorization in the U.S. could mean billions for NVAX stock. But investors are surely hedging their bets in recent weeks.

NVAX Stock at a Glance

As mentioned before, Novavax stock is down more than 40% since the calendar turned to 2022. The stock dropped 60% over the last six months, and is off nearly 70% since setting its all-time high.

Part of this fall can be attributed directly to the company’s repeated failures to apply for its EUA in the U.S. Novavax announced plans to file in the second quarter of 2021. Then it delayed to Q3, and finally to the fourth quarter.

By completing its data submission on the very last day of the fourth quarter, Novavax pushed its EUA filing to at least the first quarter of 2022. So, it’s no wonder why investors are skeptical.

On top of that, some damning articles in Politico raised real concerns about Novavax. First, the website reported in October that Novavax had core manufacturing problems in producing its Covid-19 vaccine candidate.

Then in December, Politico further reported that the Biden administration remains skeptical of Novavax’s ability to fulfill its ambitious goals.

But there are lingering concerns among top Biden officials and global health advocates about Novavax’s manufacturing facilities in the U.S. and Europe and whether the company can present the data necessary to obtain the regulatory approvals necessary to distribute doses made at those locations any time soon, according to the individual with direct knowledge of the administration’s thinking on Novavax and another individual with direct knowledge of the company’s communications with the administration.

The Politico report sent NVAX stock down another 4%.

The Bottom Line

Price targets for Novavax stock are all over the map. B. Riley analyst Mayank Mamtani maintains his “buy” rating and raised his price target for NVAX stock from $305 to $315. Cowen analyst Georgi Yordanov, meanwhile, has a $150 price target and initiated coverage with an “outperform” rating.

Novavax is seen as a key player in spreading Covid-19 vaccines around the world. Its shot does not require freezer storage, which makes it easier to ship to countries that have a lower immunization rate and a weak infrastructure.

If Novavax can win its EAU from the U.S. and show promising 2022 guidance when it next reports earnings in March, its current stock price will be seen as a huge discount.

NVAX stock could be the biggest bargain in the market right now. But investors have every right to be skeptical considering the stop-and-start company performance over the last year.

On the date of publication, Patrick Sanders did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Patrick Sanders is a freelance writer and editor in Maryland, and from 2015 to 2019 was head of the investment advice section at U.S. News & World Report. Follow him on Twitter at?@1patricksanders. As of this writing, he did not hold a position in any of the aforementioned securities.