Delcath's Disappointing Delay

• Report this Comment On April 12, 2011, at 3:34 PM, sglider wrote:

  "But investors have to ask whether management should have known the data would be required and submitted it in the first place"

  I listened to the conference call and they did address this. They stated that data the FDA is asking for was not asked for at the time of the SPA.

  "A Special Protocol Assessment (SPA) from the FDA is a contractual agreement that the Phase III trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval.

  An SPA is binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun."

  So after the testing was done and data was submitted, the FDA took another look and decided more data was needed. The only reason Delcath doesn't expect it to be more than 3 months is because they feel no more trials need to be performed to answer the FDA's questions.

  Given how the FDA works, I don't see this as a huge sign of incompetence by the management. And given that the CE Mark decision is nearing, that is why the stock is not tanking.

  A three month delay is important. I don't want my money not making money. But given that the CE Mark hype is around the corner, one should be able to make good money and still get out without risking a yes or no decision in June.

• Report this Comment On April 12, 2011, at 5:25 PM, TMFBiologyFool wrote:

  sqlider,

  I heard the same thing on the conference call, but it sounds like a lame excuse to me. I don't see what an SPA has to do with what data is included in the marketing application.

  Management should have asked if the FDA wanted it. Or just included it to be safe.

  (I'm fully aware I could be overreacting. The FDA has been known to be schizophrenic at times.)

  -Brian

• Report this Comment On April 12, 2011, at 6:19 PM, sglider wrote:

  Right now, I'm not too concerned about the FDA and what did or did not get submitted. The next thing of importance for Delcath shareholders or potential shareholders is the CE Mark. That is what will drive share price. The question is, did they fill out everything correctly and give enough information to get approved.

  I do agree there is a virtual warning sign blinking about Delcath considering the handling of the FDA application. If the CE Mark isn't approved, those 3 months loom much larger and additional long delays might start meaning dilution.

  Still, if you want to make money, the timing is great if you only want to play it safe and buy on hype/sell before news.

• Report this Comment On April 13, 2011, at 10:51 AM, mblk523 wrote:

  FDA asking for something not previously discussed is definitely not lame. I am a Regulatory Affairs professional in the Medical Device industry, FDA constantly asks for information it did not mention as being important in early discussions. Also, adding information to a submission that is not agreed upon is not good strategy either because FDA will ask for more on that as well as the other Q's. Not terribly efficient, but the best way to deal with FDA is what Delcath is doing - submit, get Q's, discuss with FDA in detail, resubmit. The important this for the investment community to keep in mind is that this is not a 'science' thing, it's a political (CYA) thing that FDA does everyday with novel treatments.

• Report this Comment On April 13, 2011, at 12:31 PM, Momentum21 wrote:

  as Flavor Flav would say...yeah boy! Light the lamp

• Report this Comment On April 13, 2011, at 3:23 PM, tumiwisi wrote:

  May I congratulate you on your timing guys! Like almost everything in this game, it's a pure coincidence, nevertheless you are becoming a very good short term contrarian indicator.

  Keep up the good work

  Foolishly yours

  TuMiWisi

• Report this Comment On April 13, 2011, at 4:08 PM, TBFS9 wrote:

  "becoming a very good short term contrarian indicator."

  No journalistic integrity, no fact based research pure off the cuff opinion. This is the National Enquirer of the Investment world.

  Long ago the Fool's became just that.

Add your comment.