This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Biotech Stock Mailbag: Delcath, Navidea, Affymax, Ziopharm

When Delcath designed the phase III study, it assumed patients treated with BAC would report median hPFS of about four months compared to about seven months for Melblez. Why did BAC underperform expectations so significantly? It will be interesting to read the FDA analysis of what constituted BAC in this study and whether the treatments used constituted a real comparator.

I'd also like to see the hPFS data excluding the 11% of patients with cutaneous melanoma since they're no longer being considered for approval under the amended Melblez application. I don't expect the results to change significantly but Delcath has never reported these data before.

I expect FDA and the advisory panel to raise significant concerns about Melblez's safety. Three patients out of 40 died due to Melblez during the phase III trial -- two from neutropenic sepsis and one from hepatic failure. That's a 7.5% mortality rate attributed to Melblez -- not the underlying cancer. Melblez is a risky procedure.

I also question the ability of the filters used in Melblez to keep melphalan from leaking outside the liver. Sixty-one percent of patients treated with Melblez reported serious (grade 3 or 4) neutropenia, 74% reported serious thrombocytopenia and 46% reported serious anemia.

Delcath changed out the filter in Melblez but the company hasn't disclosed any new safety data. (Although the company claims the "Gen 2" filter is better.) On a conference call Wednesday night, Delcath executives said the FDA advisory panel would spend considerable time reviewing the company's proposed risk-management plan for Melblez. To me, this is a tacit acknowledgment that Melblez's safety is a regulatory concern.

The road leading to the May 2 FDA advisory panel has been rough for Delcath. Remember, Melblez was first submitted for FDA approval in late 2010. FDA issued a refuse to file letter, requiring Delcath to re-submit with additional manufacturing and safety data. We have never seen these new safety data. Delcath has not been as transparent with Melblez data as I'd prefer, so I won't be surprised to see some unpleasantness aired by FDA when the briefing documents are posted publicly.

2 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,079.57 -42.44 -0.25%
S&P 500 1,996.74 -3.38 -0.17%
NASDAQ 4,557.6950 -11.9260 -0.26%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs