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UK any idea what Deepak had in mind
when he mentioned in the Last interview, that we would get exciting news in the very best future?
TC Pix
My guess for the First deal: Smart Insole.
Any thoughts?
Best Pix
Update: http://goo.gl/MWM4B
Fibromyalgia program is nice,..
Best Pix
Question to all:
Would such an App be covered by
biels Patents?
Best Pix
To my opinion it all comes down to marketing power.
TV ads, certain news paper ads, gadgets for pharmacists, web based ads, sales reps - These are the costly Ingredients for success. I doubt that small distributors can do that.
That is why we Need One or More Big Pharma partners to sign up.
I hope Andy will deliver soon After reclass and 510K approval.
Best Pix
When will they provide fins?
Anybody?
Also to me?
Edbi46
Could you pls disclose the thing to me too? Ingoxx@hotmail.com
Thx Pix
Hi Simps
I invested USD 60000 for 12 Mio shares for 0.005 each.
Hope also to get out positive...
Best Pix
Hi 7
How do you end up with class 1?
Best
Talked to Melissa Burns today.
According to her, it could take several months, as it is a very large docket.
But of course she could Not go into details.
I am Long 12 Mio shares and just hope it works out ...
Best, Pix
Is somebody Recording?
Best, pix
*Existing literature do not conclusively demonstrate safety and effectiveness of the nonthermal SWD.
Hope BIEL can professionally deal with this.
Pix
I See, allay may be First then?
Just hope, they have rock solid new clinical trial data for actipatch, recoverex...
What do you mean?
Why didnt they go "de Novo" or do i miss this?
An applicant of a 510(k) who receives a Not Substantially Equivalent (NSE) determination placing the device into a Class III category can request a de novo classification of the product into Class I or II. The request must be in writing and sent within 30 days from the receipt of the NSE determination. In addition, the request should include a description of the device, labeling for the device, reasons for the recommended classification (into Class I or II), and information to support the recommendation. The de novo process has a 60 day review period. If FDA classifies the device into Class I or II, the applicant will then receive an approval order to market the device. This device type can then be used as a predicate device for other firms to submit a 510(k). However, if FDA determines that the device will remain in the Class III category, the device cannot be marketed until the applicant has obtained an approved PMA.
Dubb do you still See it als OTC?
In the FDA proposal there is a Lot of Talk about General controls, which basically means prescription ....
Best Ingo
Excellent points flipper.
Obviousely the production process
generating the perfectly staged immature DC is key.
Looks like NWBO has sorted out many problems and is certainly very well positioned. Data will have to prove, though...
DCVax (Direct) looks like the perfect Combi approach.
Best Pix
What do you estimate now about start of ph2/3?
My guess end of Q1 2014.
Yours?
What do they mean with crossover?
2 groups, one get Abacavir, the other P? Measuring plasma levels of A as marker?
BK - just to be clear:
They now have to do this Ph1 study, right? This will take a month?
Results are necessary for IND?
What about the Bridge study they have performed and announcef as successful? Not sufficient?
Pls advise.
Best Pix
For me the best part:
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented, "Since last month's Elsevier conference, we have entered into two confidentiality agreements with multi-billion dollar companies interested in our pipeline. We have a lot to accomplish over the coming weeks, which should set Cellceutix up for an exciting new year. We will provide shareholders with a more comprehensive update during the JP Morgan conference in January 2014."
Enoy, Pix
Cellceutix UPDATE:
BEVERLY, MA--(Marketwired - Dec 9, 2013) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, today updates shareholders on recent developments and future plans. A comprehensive update will be provided to shareholders in mid January 2014.
Prurisol: Cellceutix has corresponded with the U.S. Food and Drug Administration (FDA) in preparation for clinical trials of Prurisol as a new oral drug candidate for psoriasis. The FDA has advised the Company that a 505(b)(2) designation is an appropriate pathway for development of Prurisol. Because Prurisol is an ester of abacavir, the FDA has requested that Cellceutix conduct a short Phase 1 crossover study to demonstrate that Prurisol converts into abacavir in humans before initiating a larger-scale Phase 2/3 trial. Cellceutix is selecting the site for this study and the protocol will be submitted to the site's Institutional Review Board (IRB) for approval. Cellceutix plans to accomplish this by the end of this month. It is anticipated that the trial will take one month to complete.
Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI): The Company has selected clinical sites for the phase 2b trial and is finalizing requisite documentation for submission to the respective Institutional Review Boards by the end of this month. The Investigational New Drug application for Brilacidin for ABSSSI is active with the U.S. Food and Drug Administration (FDA). After IRB approval, the Company may immediately commence with its Phase 2b clinical trial, which is planned for January 2014.
Kevetrin: The sixth cohort has completed dosing in the Phase 1 clinical trial of the Company's anti-cancer drug Kevetrin being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet in mid-December to define the increased dose for the seventh cohort. Maximum tolerated dose of Kevetrin has not yet been reached. Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours. Cellceutix filed the amendment to keep the dosing time frame within a reasonable number of hours as the dosing level increases as the trial progresses.
In addition to the above listed projects, Cellceutix staff is conducting research with Brilacidin for oral mucositis, ophthalmic diseases and otitis as well as other projects previously announced.
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented, "Since last month's Elsevier conference, we have entered into two confidentiality agreements with multi-billion dollar companies interested in our pipeline. We have a lot to accomplish over the coming weeks, which should set Cellceutix up for an exciting new year. We will provide shareholders with a more comprehensive update during the JP Morgan conference in January 2014."
BK - this is the basis for my comment, that we may be at the edge of efficacy levels.
Of course a repeated dosing per week eg 2-3x would be a different story...
With every cohort from now on,
It may get really exciting.
It just will take more time, but may establish the basis for outstanding results.
Best Pix
Thx BK - i agree, that with current dosing, we are at the edge of potential efficiency.
But for outstanding results we may need higher concentrations...
Hoping for the best,
Pix
I hope you are right, but K showed outstanding results @ 200mg/kg.
HED= about 16mg/kg
For a 60kg patient: 960mg total
and this translates to about 450mg/m2
Best, Pix
Muelch - i tend to agree.
Mice studies produced significant/outstanding results at quite high levels.
Would really hope they increased dosages at higher pace, but of course safety first...
400-500mg is the range i would be hoping for, but this will take some more time.
Best, Pix
I am pretty surprised, because that would mean DLT expected soon
Or would they just stop to come to conclusion and proceed with 1b?
I was actually hoping for MTD in the range of 400-600mg/m2...
Anyone?
But DF should know best...
Best Pix
Leo ruled out a reverse split, such as Adxs did:
Update on Advaxis Announces 1-for-125 Reverse Stock Split and Decrease in Authorized Shares of Common Stock
Best, pix
Some more market activities regarding Oral Mucositis:
Just a pain reliefer, no antibiotic, but MSKCC finds it interesting...
If B does what it showed preclinically, we may have a REAL MED solution for those poor guys suffering from OM - there is definitely BIG, BIG need out there.
Best, Pix
Gelclair(R) Placed on Memorial Sloan-Kettering Cancer Center Formulary as Exclusive Product to Treat Patients With Oral Mucositis
http://finance.yahoo.com/q?s=dara
About Oral Mucositis
Oral Mucositis (OM), characterized by painful acute inflammation and ulceration of the surface of the mouth and throat in cancer patients, is caused by chemotherapy and radiation treatment, which disrupts rapidly dividing epithelial progenitor cells. It is estimated that approximately 400,000 cases of OM are diagnosed annually. OM can be an intensely painful condition that often leads to difficulties swallowing food and fluids, potentially leading to dehydration and malnutrition. OM can also lead to delays in cancer treatment, through chemotherapy dose reductions, breaks in radiation treatment, cessation of cancer therapy, hospitalization and reliance on parenteral nutrition. Whereas OM is a common complication of treatment with broadly cytotoxic chemotherapeutic agents or even targeted cancer drugs, it is particularly severe in patients receiving radiation therapy for head and neck cancer and in patients receiving high-dose chemotherapy conditioning prior to hematopoietic stem cell transplantation.
About Gelclair (Bioadherent oral rinse gel):
Gelclair® is an easy-to-use bioadherent oral rinse gel for the management and relief of pain associated with oral mucositis, a condition which can occur in cancer patients due to chemotherapy and radiation treatment. Gelclair has a unique hyaluronic acid-based formulation and, unlike Mugardâ„¢, Episil® and Magic Mouthwash contains no alcohol, thereby reducing the risk of painful burning and drying. Gelclair has been broadly studied, demonstrating rapid and effective relief of pain, improvement in ability to eat and drink and reduction in the need for rescue analgesics. DARA has exclusive U.S. commercial rights to Gelclair through a license with The Helsinn Group in Switzerland.
From a SA article about Soligenix:
Oral Mucositis:
This treatment has a great deal of potential which is obvious given the FDA "Fast Track" designation. However, it's also worth noting some specifics. Oral muscositis (grades II-IV) affects over 180,000 head and neck cancer patients worldwide. Additionally, this particular ailment does not currently have an approved drug, and as such, represents an unmet medical need.
Hope, Leo will file IND of B asap ...
Best, Pix
BK - yes slightly.
We just Need 3 More clear cohorts to get into power Zone
Then we may speculate about exceptionel Response.
When Do you think they develop an oral Applikation?
Best Pix
BK, thx for this.
@ 50 mg/kg performance of K and control seems to be equal. I cannot see to much of a robust effect?! Though, Sequential dosing could do the trick.
If we could get to about 300-500mg/m2 without DLT we may hit imo the jackpot.
This means About 3 more cohorts in total, starting this month at +100mg/m2
Best, Pix
Thx Farrel
Never saw this in any company statement - always psoriasis "only"
Best Pix
Thx BK
I meant specifically
"without any initial signs of limited indications"
Any idea?
Best Pix
BK, hi
What do you think Leo is telling us here:
"Prurisol is an oral agent without any initial signs of limited indications like that, so we want to get it into the clinic to prove its worth as quickly as possible."
Best, Pix
Spot on!
Best, Pix
I believe we will stay rangebound
as long as we cannot show the funding for B.
If leo can strike a favorable financing deal, we will go up...
Imho, Pix
BK, hi:
What do you mean specifically by:
Brilacidin is a billion dollar drug with a successful Phase 2a and a counter indications profile better than the current standard of care for its target disease.
Why better, than Cubicin?
Thx, Pix
Thx dmat!!
We could definitely have a highly differentiated winner:
"Among the 7 drugs in development, 2 are in phase 3 and 5 are in phase 2. In addition, the fate of one of those phase 2 drugs, Brilacidin (PMX-30063), is uncertain because its developer, PolyMedix, filed for chapter 7 bankruptcy in early April. This drug was the only 1 of the 7 believed to have a novel mechanism of action, the report reveals. "
Best, Pix
Cannot open - can you pls copy and paste
Best Pix