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Delcath Systems, Inc. Message Board

  • melikesdinero melikesdinero Jun 27, 2013 2:53 AM Flag

    Pay Day Coming Up... For a Bump, Another Value Purchase for the Small Guys.

    EAP, Gen 2, Dox on the rocks, Reimbursement in the UK soon, and in Germany 47 lined up allready. Who's going to buy CLSN at $1 and pennies instead of this? Not me... GLTA & Go Hobbs.

    Sentiment: Strong Buy

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    • melikes, you and I used to go at it about the direction of this company a few months ago. You "guaranteed" US approval by June and tore apart anyone who said you were nuts. You were screaming to buy at $2 and I sold everything at $2.20. You laughed and called me stupid. It's amazing you're still yappin' when you've been so horribly wrong. Most guys with half your ego would have gone quietly but you just get louder. Guess there's no pride or embarrassment when you can just hide behind a keyboard.
      All I can say to everyone else here is if you listen to anything this hack has to say, you're going to lose your shirt just like him.

      Sentiment: Hold

    • Gen 2 is going to have to stand on its own efficacy and safety merits.
      OK... so they have asked Hobbs and he says that they are waiting on the FDA for some indication on Gen 2... what will FDA say? We know NOTHING about FDA-Delcath relations... what has Hobbs said that is true? Report is also that Hobbs and Kandarpa habe NOT been forthcoming... that BOD has not done its homework, just followed Hobbs, etc.

      And they say that Hobbs and Kandarpa have not reported to the one who has the MOST info on P3... data has not been forthcoming... so who is doing the peer-review Alexander said before ODAC is "ready"? Pingpank was the writer and he has not been invoved with Hobbs and Koplewicz for TWO years!

      Europe is using Gen 2 and also US EAP?... there have been presentations (Zager, et al) and Italy bought some beyond the 10 free kits...

      Summary: Alexander says that peer-review publ is "ready" so where is that and when? This has been a major issue!--- as doc mentions!

      Gen 1 was 78% they said and now Gen 2 is 98%... meaning?

      Gen 2 trials--- Hobbs says he is waiting on the FDA... and what will the trials cost and how long? And DO WE have time now?--- how relevant is PHP/CS going forward. BP says co has value... but NOT with this leadership.

      HCC looks weak as Hirogen and others have said! What about neuro, colorectal, etc.--- other indications?

      Summary: Do we have a viable product!? Answer seems to be yes, but not without new Exec Chairman and CEO.

      Co is in danger!--- but Hobbs, et al are IN for the long haul... that will be years away, again! And as Binder writes, we have fallen badly since Hobbs took over July 2009.

      "Shameful" and "a disgrace" they say, regarding management and BOD performance... McD said it will be all about "execution" and that to date has been a failure... Is this BOD aware and responsible... will they allow failed leadership to continue in place? So far, yes... MST says it is a done deal.

      (Some have given up... IS Candid is absent... others are grasping at straws... and I do not need to mention HarveyB and Ryno eh?!... where is lowlear?...)

      Very interesting to go back and read HarveyB... did he have some inside info on FDA view?

      BP today thinks stock can go lower but .40 is very low...

      Thanks! Neal

      PS--- from 2 MDs: Co was 'warned' about FDA response re: NDA submissions 12/10 and 8/12; Hobbs and Harold K ignored advice...
      "malpractice", eh...! Hobbs has been severely criticized, and see doc's post--- what has been going on since 6/10 with the FDA!!!, and:

      (post ODAC) " better hurry. Hobbs shows he doesn't know how to deal with the FDA. Tread lightly in your public statements, make your case to the FDA with data behind the scenes. As a tiny development stage biotech, know your place. He may have a point on some of the safety issues, but it depends on nuances, looking at incomplete data in a certain way. Publicly calling out the FDA, i.e. Pazdur, as "mis-characterizing" PHP safety isn't going to get the company ANY breaks in a situation where even one is needed badly."

      Some wonder whether or not we can prevail/survive, so that needs to be examined independently now. Meanwhile, Hobbs, Koplewicz, BOD are not listening!

      BP tells me that they are now at the beginning again and it will be two-three years out for Gen 2 and Europe... maybe some co will buy this thing if Europe looks good at all or FDA approves Gen 2 some day... New longs can be in at .40 but .20 likely as well...

      Thanks, Neal

    • Say what you will, but this stock is waaaaay oversold, on FDA news. Not down because of EU news - only good news coming from across the pond. Takes time, buying during the uncertainty is where we're gonna make the BIG dollars. GL.

      Sentiment: Strong Buy

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