As the Biotech Saying Goes...

Don't let it get away!

Keep track of the stocks that matter to you.

Help yourself with the Fool's FREE and easy new watchlist service today.

Fool me once, shame on you; fool me twice, shame on me; fool me thrice, hit the sell button.

OK, so I just made up that last part, but yesterday, Protalix BioTherapeutics' (AMEX: PLX  ) investors seemed to be following the mantra as they sent the stock down 13% following the company's announcement that the Food and Drug Administration had pushed back the decision on whether to approve taliglucerase alfa by three months.

You'll recall -- or maybe not, considering how long ago it was -- that almost two years ago, the FDA asked Protalix and marketing partner Pfizer (NYSE: PFE  ) for more data on the manufacturing process for taliglucerase alfa. After it gathered the data and submitted it the FDA, the agency said it wasn't good enough and asked for more information.

After the duo submitted a second marketing application, the FDA set a goal of making an approval decision by Feb. 1. Unfortunately, the agency asked for more clinical data during the second review, and decided it needed until May 1 to make a decision.

Orphan drugs have become a lucrative business as BioMarin Pharmaceutical (Nasdaq: BMRN  ) and Shire (Nasdaq: SHPGY  ) have shown. They were the driving force for Sanofi (NYSE: SNY  ) to buy Genzyme. But this is getting a little ridiculous, and I don't blame investors for moving on.

Protalix uses plant cells to manufacture the drug. The novelty has its advantages, lower costs among others, but the novelty seems to be coming with added scrutiny from the FDA. Since the manufacturing side tends to be a black box for investors, it's difficult to assess the risk of another rejection.

The delay could be nothing. It could be the last one. This could be an excellent entry point. But "coulds" aren't very reassuring. Unfortunately, there's just no way to know if Protalix has finally submitted enough data to convince the FDA to approve taliglucerase alfa.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of BioMarin Pharmaceutical and Pfizer. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 1737921, ~/Articles/ArticleHandler.aspx, 10/24/2016 4:19:26 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,223.03 77.32 0.43%
S&P 500 2,151.33 10.17 0.47%
NASD 5,309.83 52.43 1.00%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/24/2016 3:59 PM
PLX $0.50 Down +0.00 -0.98%
Protalix BioTherap… CAPS Rating: **
BMRN $82.14 Down -0.14 -0.17%
BioMarin Pharmaceu… CAPS Rating: ***
PFE $32.13 Down -0.05 -0.16%
Pfizer CAPS Rating: ****
SHPG $181.29 Down -3.11 -1.69%
Shire CAPS Rating: ***
SNY $37.76 Up +0.01 +0.03%
Sanofi CAPS Rating: *****