This Day On The Street
Continue to site right-arrow
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!

Prepping for Aveo, Delcath FDA Panels

Stocks in this article: AVEO DCTH

BOSTON ( TheStreet) -- A reminder and a semi-shameless promotional plug: On Thursday, I will be live-blogging the back-to-back FDA advisory panels scheduled to review Aveo Oncology's (AVEO) kidney cancer drug tivozanib and Delcath Systems' (DCTH) Melblez, a hybrid, surgical-chemotherapy procedure designed to eradicate tumors from the liver caused by a form of melanoma.

Before we get to the expert panel deliberations, the FDA's own review teams will weigh in on the pros and cons of both products, issuing "briefing documents" on Tuesday morning. You'll be able to find the FDA reviews of tivozanib and Melblex on the FDA's web site.

Expect volatility in Aveo and Delcath trading tomorrow, depending on the tone of the FDA reviews.

Healthcare investor and commentator Aafia Chaudhry -- she can be followed on Twitter at @aafiac -- will join the live blog as guest host. Chaudhry is predicting positive panel votes for both Aveo and Delcath, which is exactly the opposite of how I see the panels going.

You can read Chaudhry's bullish stance on Delcath's FDA panel here. Money quote:

Ultimately, we believe the data suggest a meaningful efficacy signal; the procedure is safe and well-tolerated; the sponsor has met the conditions of the SPA; and FDA appears to be working with the sponsor to map out the most efficient course to bring Melblez to market. Given that Melblez is already commercially available in 7 EU countries and that FDA has approved a US Expanded Access Program , we feel this mitigates any residual risk associated with the manufacturing component of the NDA and expect a positive ODAC vote and subsequent approval.

I'm bearish on Delcath because of questions about the clinical meaningfulness of Melblez's efficacy and red flags in the safety data. My full take on the Delcath bear thesis can be read here. Money quote:

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.

If the market is a barometer, Delcath's week ahead looks stormy. At $1.45, the stock is down 32% from its year-high reached March 11 and 5% today.. The "Bio-Run Up" into the Melblez panel predicted by some never materialized.

On the sell side, Wedbush analyst Greg Wade is predicting a positive FDA panel vote for Delcath.

On Aveo, Chaudhry recent detailed her reasons why Thursday's panel will vote to recommend tivozanib's approval. Likewise, I explained why the FDA and panel experts are more likely to vote against tivozanib.

The sell side is similarly split. RBC Capital Market analyst Adnan Butt:

The Street remains cautious given a Phase III trial design that confounded OS outcomes. However, we believe tivozanib's risk-benefit profile is favorable, clinically meaningful (better than currently marketed drugs), and unfavorable OS trends (not statistically significant) are explainable. We believe that even if the briefing documents read cautious, the actual meeting is unlikely to follow suit with ODAC understanding the negative OS trend, higher relative efficacy, and better tolerability and safety. On balance, consultants believe the trial did what it set out to do and tivozanib is unlikely to be rejected by the FDA. Given the "out of favor" sentiment, should tivozanib receive a recommendation for approval, we think there could be room for significant upside.

Stifel analyst Brian Klein:

We forecast a negative recommendation by ODAC on May 2, making the subsequent FDA decision an easy one. Rather than accepting excuses for why the PFS/OS data is inconsistent, we anticipate the the panel will refute management's argument that crossover in the TIVO-1 trial sufficiently explains why Tivozanib survival trended lower than the comparator arm. With the availability of several alternative front-line therapies with similar PFS durations, thereby negating the unmet need, we believe the panel will recommend a pre-marketing confirmatory trial, allowing the FDA to forego Tivozanib approval.

Aveo shares are down 8% year to date.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

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 18,030.21 +6.04 0.03%
S&P 500 2,081.88 -0.29 -0.01%
NASDAQ 4,773.4720 +8.0480 0.17%

Brokerage Partners

Rates from

  • 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