By Ray Blanco
This post From the Ashes of Failure: A Biotech Phoenix Rises appeared first on Daily Reckoning.
Thanks to a dogged immune-centered biotech, it looks like we are well on our way toward a better hepatitis B vaccine.
We really need one.
This viral infection attacks the liver and can cause both acute and chronic disease. Worldwide, hundreds of millions of people have it, and hundreds of thousands die from complications brought on by the infection every year.
We’ve had vaccines available in recent years… but they are far from perfect. They require multiple shots over a period of several months.
This means that the protective effects of the vaccine take time to take hold… and you can become infected over the interim. Furthermore, the vaccine schedule is hard to comply with, meaning many people who start never finish — and therefore never receive the benefits.
Thankfully, one company is on the verge of bringing a new vaccine to market very soon.
The company had tried and failed before. They have brought the vaccine to the FDA twice, and twice the FDA has shot it down, wanting more data. This has added years of development to the vaccine, since the company has found it necessary to run additional clinical trials to produce more data for the FDA.
Past failure had made future success seem unlikely, as many investors have been put off by the heightened risk… but that just makes a regulatory win more of a surprise, with potential for greater upside.
That upside is materializing now before our eyes. Very recently, the FDA’s advisory panel issued a strong positive vote in favor of the vaccine’s safety — by a margin of 12-to-1.
Safety was the original problem the FDA had with the vaccine.
Although the previous advisory committee overwhelmingly voted in favor of the drug’s efficacy (by a 13-to-1 margin), the FDA’s safety concerns shot down the company’s marketing application.
And now we have a positive safety vote, making it much more likely that the FDA will approve the vaccine.
The potential for FDA approval has already significantly moved the needle for this company, too. By last Monday morning, their shares opened up nearly 80% from their Friday closing price solely on expectation.
And share value could shoot even higher with the announcement of a full approval. And if the result comes back favorably, this vaccine could generate peak sales in the neighborhood of half a billion dollars a year.
An approval could also shoot the share value through the roof. We could see the market cap well in excess of $1 billion in a week or two — and that could double your money in the same time.
We’ll know very soon, within the next day, as to what the FDA results are. If things break as expected, your next windfall of cash could be right around the corner. And I’ll be sure to keep in you in the know as things develop on this exciting new breakthrough.
To a bright future,
for The Daily Reckoning
Source:: Daily Reckoning feed
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