I'm no lawyer, but I thought the motion to dismiss written by Sullivan was/is bullet proof. One by one he quoted each complaint and presented 4 to 5 intelligent responses(not just one) to each complaint proving the complaint meritless by either citing case law or referencing info provided by ctix(often the 10k's).
A good lesson in critical thinking and expository writing. We'll see how Rosen responds. They may need more than the 30 days allowed, there are some big words in that motion.
Should hear something about their meetings with FDA concerning the method of application regarding Gen-1 and glioblastoma. On 11/5/15 MT noted 3-4 months. 4 months will be 3/5/16. Will likely announce the collaboration(s) he spoke of that same cc if an agreed upon method of application is reached(I think he said it's not a matter of if, but when). I think BT is out, should of heard by know. Don't think they'll sell the company. Hopefully start to hear about the mytomorrows trials and Dignity Europe.
On 1/5/16 Judge Failla issued an Order stating:
The Plaintiffs submit second amended complaint(SAC) by 1/11/16
The Defendants submit motion to dismiss by 2/10/16
Plaintiffs opposition to motion to dismiss by 3/11/16
Defendants reply to Plaintiffs opposition by 3/25/16
She also noted there would be no extensions to any of the above absent exceptional circumstances.
DEFENDANTS’ MEMORANDUM OF LAW IN SUPPORT OF THEIR MOTION TO DISMISS SECOND AMENDED COMPLAINT
Kim must be illiterate. Looks like a complete dissection of the cancer(Rosen).
Maybe they bumped into each other in Dublin, or the one employee in Ireland knocked on MDT's door, after all that's where Nephros' satellite office is and where MDT is based out of.
Good post, hope those time lines prove correct.
All I know is that these guys have proven themselves to be built for comfort, not for speed.
Patiently waiting....12 years now:(
Are either of these trials noted on the clinical trial site? I think not.
The following is from clsn's website:
To generate growth over the long-term, we are supporting a broad range of studies using MRI-guided high-intensity focused ultrasound (HIFU) to provide ThermoDox activation in multiple indications. The most advanced program is recruiting patients with colorectal liver metastases in a Phase II study, in partnership with Oxford University in Britain. That program is followed closely by a Phase II study of ThermoDox + HIFU in patients with breast cancer in The Netherlands. Both of these programs are co-funded in Europe by government grants. Beyond those indications, ThermoDox holds promise in a wide variety of tumor types for which doxorubicin is widely used, including pancreatic cancer and glioblastoma, a type of brain cancer.
Clearly the Ph 2 Oxford trial is not the TARDOX study noted on the CTS site, which is PH I. Nor is the Netherlands phII the same as the CTMM trial(preclinical I think). BTW, CTMM is no longer, they ceased about a year ago and merged with TI-Pharma and are now known as Lugature.
Something's going on.
That's all folk's,
And dignity is not their top priority. Per the 3rd q cc, MT responded to an analysts question regarding priority sequence to which MT listed as: #1- Optima, #2- GEN-1 for ovarian cancer, #3- RCW(Dignity and Europe), #4- lung delivery platform (TheraSilence), #5- GEN-1 for Glioblastoma multiforme (GBM).
He went on say that they are currently working on a "method of administration" of GEN-1 for GBM patients. Expect that to take 3 to 4 months(from 11/5/15). Once they (CLSN) have that lined up they would start working with FDA to establish trial protocol and would see a phase 1 trial, at the earliest, the 2nd half of this year. He also noted that because GBM is an aggressive and fast acting cancer, that they would know in a rather short period of time whether or not GEN-1 is effective. He also said recruitment numbers would be on the smaller end, indicating GBM trials would move much faster than say HEAT, OPTIMA, DIGNITY. He said the GBM indication could become their top priority in a relative short period of time if they get the results they think they can based on pre-clinical data and effective method of administration.
I agree. This case will be decided by a judge who is loaded with intelligence and strong character.
She will quickly assess the merits of the case based on the accuracy of the info presented, and the quality and integrity of those before her . My rating of those in that court room(highest to lowest):
She'll do her homework.
For sure you have been spot on, to my discouragement since I'm long. Up till now, you've proven management's robust opines wrong, consistently. Something stinks, not sure from which end the stench comes(at least you respond to questions:).
1.50 equals .333 prior to the last rs. Odaat had the numbers right, just misplaced the decimal point:).
Interesting, nice find. In reading through it, it appears tdox was also approved in 2015 under this AT&T plan, along with a whole host of other drugs not yet fda approved, but also in the midst of a clinical trial.
Could it be that insurance companies lower their expenses by allowing clients to participate in clinical trials?
Things have, looking forward, appeared "compelling", "robust", and "perhaps curative" on the thermodox front for quite some time per Tardugno. TDOX(Lyso-Thermosenstive Liposomal Doxorubicin (LTLD)) seems to slowly be taking a back seat to GEN-1 and Egen "products" in my view.
Is Celsion up and running on mytomorrows? All I see for hcc on that site is Therasperes. Don't see info tdox and breast cancer either. Hoping I'm doing something wrong, or perhaps, the link has yet to be established.
Hope you are correct, but must say I don't harbor the same thoughts. Who knows(other than clsn/fda), I don't think either party is obliged to tell us anything.
16) Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).
Nice find! Could be nothing, but I doubt it. Although Nephros does not appear to be a member of KHI(Kidney Health Initiative), two people, out of ten that make up the "hemodiafiltration subgroup", who contributed to the article you noted are Nephros Inc employees. Those two are Greg Collins(been with Nephros from the start and a former Fresenius employee) and Jim Summerton. The other 8 making up the "hemodiafiltration subgroup" are: 3 from the FDA: Gema Gonzalez, PhD, Shani Haugen, and PhD, Shen Xiao, MD. 2 from Fresenius: Benard Canaud, MD and Robert Kossmann, MD, FACP, FASN. 1 from NX Stage(Todd Snell), 1 from Nephro-Solutions AG - Germany( Jorg Vienken, PhD), and 1 from Vanderbilt University(William Fissell, MD).
Wonder when this was released?