Hallo werthe DCTH Gemeinde,
bei DEN hohen Volumen seit ich den Laden im Bestand habe (seit letzten Donnerstag...) und die hier zu sehen sind, kann das eigentlich nur Gutes bedeuten...
Alleine gestern am frühen Abend von 0,27 innerhalb von 30 Sekunden runter auf 0,18 u. dann gleich wieder rauf bis 0,23....DA KAUFT JEMAND MASSIV EIN und ohne entsprechendes Insiderwissen würde das niemand tun sondern den Kursverfall nach unten den Shortern überlassen, sowas habe ich in meinen 27 Börsenjahren schon sehr häufig erlebt wenn NIX dahinter war !!!
Dies ist nur meine persönliche Meinung und KEINE KAUFEMPFEHLUNG und erst recht keine Verkaufempfehlung....grins
Die FDA Zulassung wird lt. HP Delcath (www.delcath.com unter Punkt Investor Presentation) wohl 2019 soweit sein.
Die FDA hat am 05.06.2017 wohl die Erlaubnis für die letzte Prüfphase (Phase 3 Trials) gegeben.
In Europa ist das Verfahren schon im Einsatz u. bei weiterem Erfolg (die Zulassungsbedingungen sind in Europa niedriger als in "Trumpland") werden wohl auch hier weitere Orders kommen.
Insgesamt einfach ein super Produkt aus meiner Sicht u. ein langfristig super Investment - erst recht wenn die FDA mitspielt...schaun mer mal...
:-)
So jetzt hier endlich die eigentliche Meldung
Quelle:
www.wallstreetpr.com/...g-the-various-concerned-parties-39404
FDAs Approval For The Study Design By Delcath Systems, Inc (NASDAQ:DCTH) Sparks Excitement Among The Various Concerned Parties
By
Chris Brown -
June 5, 2017 9328
Delcath Systems, Inc (NASDAQ:DCTH) has moved ahead to state that the Food And Drug Administration has given approval to its design of a clinical trial for its Melphalan/HDS drug product and that is of course in line with Special Protocol Assessment.
As a matter of fact, A Special Protocol Assessment (SPA) happens to be a procedure through which the FDA comes up with an official evaluation and confirmation for a yet-to-be-completed Phase 3 trials design, clinical endpoints, protocols as well as statistical analysis in a bid to form ground for a New Drug Application.
Melphalan/HDS (short for Melphalan Hydrochloride for Injection) which is combined with Delcaths Hepatic Delivery System, happens to be Delcaths drug which is specifically designed in a bid to try and administer top and trusted chemotherapy doses to the liver.
As a matter of fact, to this particular point the Melphalan/HDS system hasnt yet received approval in the U.S, but one thing that is for sure is the fact that it is seen as a combination drug-and-device product.
The agencys SPA nod has gone ahead to say that the trial design in an adequate way addresses the set goals for evaluating Melphalan/HDS for handling the wide range of patients with intrahepatic cholangiocarcinoma (ICC).According to some close sources, about 295 patients are expected to be enrolled in the global trial at 40 different sites in Europe and in the U.S.
There are hopes that by the fall of 2017 the trial will have kick started and as a matter of fact it will bear the overall survival (OS) as its primary endpoint.
Measures of progression-free survival (PFS), safety as well as overall response rate (ORR) are expected to constitute the wide array of the exploratory and secondary endpoints. It is also important to point to the fact that it isnt easy to reach the point the provider has reached at the moment since on the way it is usually marred by numerous challenges.
In fact there comes a moment when efforts appear like the drawing of lines in the sand. However, the top notch provider has remained dedicated to coming up with top most solutions and for sure the future looks quite promising.
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