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Dear NPC1Parent,
my post has completely differnt meaning but you gave a way out to someone who was completed quite for 2 days...
I appreciate your posts.
Includes a lot valuable info. the most of them are known to me.
i have just one addition regarding the approval process
for rear deceases are 2 ways.
The safe one, if we can say this, to go step by step fase 1 ...face 2 ...face 3 etc
and the more risky way. to run something for more solid results and to chase a conditional approval from the FDA after face 1.
of course nobody knows what will happen at the end of the day and what the managment of CTDH have in mind...
for your situation i wish you all the best and hopefully a treatment to work for you after all
sent from mobile
please excuse eany bad spelling or typos
No comments on VTS-270?
So quite... most probably because you talk too much about it
•VTS-270, a cyclodextrin-based drug candidate in clinical development by Mallinckrodt, did not meet its primary objective in the pivotal Phase 2b/3 trial.
https://seekingalpha.com/article/4307548-mallinckrodt-vtsminus-270-niemann-pick-disease-type-c-competition
In our recently completed registration trial, the product did not show a statistically significant separation from placebo. But importantly, neither the VTS-270 nor the placebo arm showed disease progression as would have been anticipated in a neurodegenerative condition over 52 weeks of observation.
The expectation was that both treatment groups in the study would worsen over the trial period but that the VTS-270 treated group might show an attenuated course based on an accrued benefit.
Accordingly, our review of the data from the Phase 2b/3 trial has required substantial effort and still continues. We expect a better understanding of the potential benefit of VTS-270 to emerge as we carefully consider the totality of data available to us. This is an important step.
CTD Holdings Submits Application for Listing on NASDAQ
GlobeNewswire•June 12, 2019
ALACHUA, FL, June 12, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- CTD Holdings, Inc. (CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced that it has submitted its application to list its common stock on the NASDAQ Capital Market.
The Company’s management has completed the application and submitted the request to list on The Nasdaq Capital Market. The listing of the Company’s common shares remains subject to the approval of NASDAQ and the satisfaction of all applicable listing standards, including the minimum share price requirement.
As more information becomes available, the Company will update the progress on its intended up-listing accordingly.
"We are excited to take this next step in the maturation of our company," said N. Scott Fine, CTD's Chairman of the Board and CEO. "Listing on NASDAQ will allow additional investors to support the development of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C and other indications.”
Trappsol® Cyclo™, CTD’s proprietary formulation of hydroxypropyl beta cyclodextrin, is currently being evaluated at clinical sites in the U.S., Israel, the UK, and Sweden for treatment of NPC, a rare genetic disease that causes neurologic, liver, lung and other organ dysfunction and that is ultimately fatal.
About CTD Holdings:
CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease, on a compassionate use basis as well as in three ongoing formal clinical trials (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.ctd-holdings.com
Safe Harbor Statement:
This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Investor/Media Contact:
Sitrick and Company
Wendy Tanaka
(415) 369-8447
wtanaka@sitrick.com
CTD Holdings, Inc. has obtained preliminary data suggesting that Trappsol®
Cyclo^TM, its proprietary formulation of hydroxypropyl beta cyclodextrin,
crosses the blood-brain-barrier in individuals suffering from Niemann-Pick
disease type C. Data were derived from initial subjects participating in CTD's
phase I clinical trial in the United States (“A Phase I Study to Evaluate the
Single- and Multiple-dose Pharmacokinetics of Intravenous Trappsol Cyclo
(HPBCD) in Patients with Niemann-Pick Disease Type C (NPC-1) and the Effects
of Dosing Upon Biomarkers of NPC Disease," NCT02939547), and phase I/II
clinical trial in Europe and Israel ("A Phase I/II Study to Evaluate the
Safety and PK of IV Trappsol® Cyclo^TM (HPBCD) in Patients with Niemann-Pick
Disease Type C and Pharmacodynamic Effects of Treatment Upon Markers of
Cholesterol Metabolism and Clinical Outcomes," NCT02912793). Following
intravenous administration of Trappsol® Cyclo^TM ^ to study subjects, it was
detected in subjects' cerebrospinal fluid. The clinical significance of these
findings will be determined as part of the final analysis of both clinical
trials.
read carefully what you upload!
the mind is like a parachute it only works when it is open
cheers
short interest? irrelevant amount of shares
common don't fool yourself
all this and especially the technical analysis is completely nonsense in a low volume penny stock
I told you once and I am telling you again.....
and you are always mislead especially with your post regarding the law suit....
one more time you are trying to mislead!!!!
this should be fun and will support further the CTDH case
enjoy
Cyclodextrin has been stolen and now sold for $200 million dollars!! It's going to a billion++ dollars when approved. This was a drug funded and created by all of you who helped us.”
Soon after reaching out to the Hempels and agreeing to a joint venture, Cydan formed Vtesse, a company dedicated to developing drugs for Niemann-Pick Disease Type C and other rare diseases. In April 2017, Vtesse was purchased by Sucampo Pharmaceuticals for $200 million, in large part because of the same treatment, the suit says, the Hempels were in contract to develop.
•In December 2017, Sucampo was purchased by Mallinckrodt, a global pharmaceutical company, for $1.2 billion. The press release highlighting the acquisition mentions the development on the cyclodextrin being part of the billion-dollar deal.
"Cydan, Vitesse, and Sucampo swooped in to misappropriate the Hempels' confidential information and trade secrets, developed a directly competitive treatment, and sold it to an international pharmaceutical company for hundreds of millions of dollars," the lawsuit said.
CTD Holdings' European Clinical Trial Adopted by National Institute for Health Research of England
2018-01-16
Collaboration Will Provide Infrastructure Support to Study
ALACHUA, FL -- (Marketwired) -- 01/16/18 -- CTD Holdings, Inc.
(OTCQB: CTDH), a clinical stage biotechnology company that develops
cyclodextrin-based products for the treatment of disease with unmet
medical need, announced today that the company's Phase I/II Clinical
Trial "A Phase I/II Study to Evaluate the Safety and pK of IV
Trappsol® Cyclo™ (HPBCD) in Patients with Niemann-Pick Disease Type C
(NPC-1) and the Pharmacodynamic Effects of Treatment Upon Markers of
Cholesterol Metabolism and Clinical Outcomes" (NCT02912793) has been
adopted by the National Institute for Health Research's Clinical
Research Network (CRN) of England. The CRN makes it possible for
patients and health professionals across England to participate in
clinical research studies throughout the National Health Service
(NHS).
"We are excited and proud to be included in the work of the CRN as it
advances clinical trials to benefit patients in England," said CTD
Chairman and CEO N. Scott Fine. "CRN support is another means through
which we can complete our study swiftly."
CRN meets the costs of NHS staff that support research; provides
specialist training so that patients can be confident that research
is being delivered by experienced front-line staff; meets the costs
of using NHS facilities and equipment needed in the course of
studies; and, provides practical help in identifying and recruiting
patients however needed.
CTD supports two sites in England: Salford Royal Foundation NHS Trust
under the leadership of Dr. Reena Sharma, and University College
London Hospitals NHS Foundation Trust under the leadership of Dr.
Robin Lachmann.
About CTD Holdings:
CTD Holdings, Inc. is a clinical-stage biotechnology company that
develops cyclodextrin-based products for the treatment of disease.
The company's Trappsol® Cyclo™, an orphan drug designated product in
the United States and Europe, is used to treat Niemann-Pick Disease
Type C, a rare and fatal genetic disease, on a compassionate use
basis as well as in formal clinical trials. Additional indications
for the active ingredient in Trappsol® Cyclo™, are in development.
For additional information, visit the company's website:
www.ctd-holdings.com
Safe Harbor Statement:
This press release contains "forward-looking statements" about the
company's current expectations about future results, performance,
prospects and opportunities. Statements that are not historical
facts, such as "anticipates," "believes" and "expects" or similar
expressions, are forward-looking statements. These statements are
subject to a number of risks, uncertainties and other factors that
could cause actual results in future periods to differ materially
from what is expressed in, or implied by, these statements. The
factors which may influence the company's future performance include
the company's ability to obtain additional capital to expand
operations as planned, success in achieving regulatory approval for
clinical protocols, enrollment of adequate numbers of patients in
clinical trials, unforeseen difficulties in showing efficacy of the
company's biopharmaceutical products, success in attracting
additional customers and profitable contracts, and regulatory risks
associated with producing pharmaceutical grade and food products.
These and other risk factors are described from time to time in the
company's filings with the Securities and Exchange Commission,
including, but not limited to, the company's reports on Forms 10-K
and 10-Q. Unless required by law, the company assumes no obligation
to update or revise any forward-looking statements as a result of new
information or future events.
Investor/Media Contact:
Sitrick and Company
Wendy Tanaka
(415) 369-8447
wtanaka@sitrick.com
Thomas Mulligan
(212) 573-6100, Ext. 395
tmulligan@sitrick.com
VTSEE as I said is irrelevant with the run up of SCMP...
read the news
please don't make me say them twice...
I suppose there is a sucampo board if you want to share your knowledge.
Please stop spamming this board
nothing worth to check
the run up from 10 to 16 is total irrelevant that they own VTESSE
don't mislead the board here...
"2, 5, & 10 year pivots"
in a low/no volume penny stock..
ok Lazarus... whatever.....
9-12 months might be ok...
don't focus on the tree!!!
"A drug that receives Fast Track designation is eligible for some or all of the following:
•More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
•More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
•Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
•Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
hahahahahahahaaha
you look the technical indicators for a low volume penny stock
ok man....whatever......
So why are you still here spamming around?????
please stop posting misleading articles and go back to your hole LAZARUS
as I told you many times in the past you are OFF TOPIC
get a life please
wrong Board!
the shareholders of Sucampo feeling the heat and has second thoughts for spending 200 million.
the chart of Sucampo and also the financial results of the company are showing a lot
I hope now that you are not a CTDH shareholder to stop spamming this board because Sucampo has their own board
cheers
Hey Lazarus Did you catch this news?
CTD Issues Open Letter to Niemann-Pick Disease Type C Community and CTD Stakeholders
ALACHUA, FL--(Marketwired - April 10, 2017) - CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease, today issued an Open Letter to address false and misleading statements, recently made by another public company, regarding CTD's hydroxypropyl beta cyclodextrin (HPBCD) product, Trappsol® Cyclo™, and its clinical use to treat Niemann-Pick Disease Type C (NPC). The false and misleading statements were made as part of another public company's announcement of their acquisition of a hydroxypropyl beta cyclodextrin product.
CTD Holdings, Inc. issues the following Open Letter to the NPC Community and CTD Holdings Stakeholders:
Dear NPC Community and CTD Holdings Stakeholders,
Many in the patient and investor communities have contacted us to ask about statements in the public domain made by another public company with a cyclodextrin product in clinical trials for NPC, VTS-270. As a result, CTD has requested that the FDA review and take appropriate action to address the false and misleading statements made about CTD's cyclodextrin product, Trappsol® Cyclo™, also in clinical trials.
The four specific misleading and inaccurate statements and CTD's factual corrections are:
(a) a statement that CTD's product is not likely to be able to be used intrathecally. In fact, Trappsol® Cyclo™ has been and currently is in use in compassionate use programs via three routes of administration -- intrathecal (IT), intravenous (IV), and intracerebral ventricular (ICV);
(b) a statement that intravenously administered versions HPBCDs do not cross the blood-brain barrier, or do so only in limited amounts. There are no formal clinical trial data showing that HPBCD does not cross the blood-brain-barrier in NPC patients.
(c) a statement that HPBCDs may only impact neurologic aspects of NPC disease when provided directly into the cerebrospinal fluid. In fact, CTD has presented data from its compassionate use program, demonstrating that IV administration has led to neurologic benefit in some patients, and
(d) an exaggerated claim regarding the use of VTS-270 in pre-clinical studies. In fact, VTS-270 did not come into existence until early 2015, when the parent company was established. The significant proportion of pre-clinical data generated to date in mice and cat models of NPC resulted from use of CTD's Trappsol® HPBCD and others, that existed in the market when the early work was conducted, not VTS-270.
We hope that this information sheds a more accurate light on the NPC clinical trials. We know that this information is accurate with respect to CTD's Trappsol® Cyclo™ product and its use. We thank the patient community for their trust and support of our programs, with special thanks to those who have used and are still using our product in compassionate use programs. Without the support from the patient community, and physicians working alongside us all, we would not be in our current position of recruiting patients into our US and EU clinical studies.
Sincerely,
N. Scott Fine
Chairman and CEO
CTDH CITES TRIAL DESIGN FOR NIEMANN-PICK TYPE C TREATMENT
CTDH CITES RESPONSES FROM UK MEDICINES REGULATORY AGENCY
CLINICAL TRIAL DESIGN GETS POSITIVE RESPONSES
CTD Holdings' Clinical Trial Design Receives Positive Responses From U.K.'s Medicines and Healthcare Products Regulatory Agency
2015-12-14 12:00:00.158 GMT
CTD Holdings' Clinical Trial Design Receives Positive Responses From U.K.'s
Medicines and Healthcare Products Regulatory Agency
Responses Assist CTD in Its Clinical Trial Application for
Trappsol(R) Cyclo(TM) as a Treatment for Niemann-Pick Type C Disease
ALACHUA, FL -- (Marketwired) -- 12/14/15 -- CTD Holdings, Inc.
(OTCQB: CTDH), a biotechnology company that develops
cyclodextrin-based products for the treatment of disease, has
received positive responses from a major U.K. healthcare regulator to
the clinical trial design for its Trappsol® Cyclo™ drug, which is
used to treat Niemann-Pick Type C (NPC). NPC is a rare and fatal
cholesterol metabolism disease found primarily in children and young
adults.
The Medicines and Healthcare Products Regulatory Agency (MHRA)
provided positive responses to CTD's major clinical study design
elements, including safety and toxicity, patient inclusion and
exclusion criteria, and biochemical analysis and clinical outcomes.
The MHRA advice holds that CTD has sufficient pre-clinical data to
support its clinical trial. The MHRA's responses follow its
Scientific Advice Meeting with CTD in November.
CTD will prepare a formal clinical trial application for the MHRA at
which time CTD may receive additional feedback. CTD will select sites
in the U.K. for its Phase II trial and expects to begin enrolling
U.K. patients in early 2016. The company also plans to enroll
patients in other European countries and the U.S. at a later date.
"MHRA's responses are a powerful signal to NPC patients, families and
CTD stakeholders that our Phase II clinical study design is on
target," said CTD Chairman and CEO N. Scott Fine. "We are pleased
with the positive reception and look forward to submitting our
clinical trial application to the MHRA."
CTD's clinical study design calls for intravenous administration of
Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin) in NPC patients
two years of age and older. The study will examine the effect of
Trappsol® Cyclo™ on biochemical markers of cholesterol metabolism and
clearance post-administration, as well as the drug's effect on
neurologic, lung and liver symptoms. NPC disease causes the build-up
of cholesterol in every cell of the body, leading to cognitive and
movement disorders, liver dysfunction and major organ fa
ilure.
"The elements of CTD's clinical study design were drawn largely from
protocols using Trappsol® Cyclo™ in compassionate use programs around
the world," said Dr. Sharon Hrynkow, CTD's Senior Vice President for
Medical Affairs. "We are particularly grateful to the NPC families
and physicians from the U.S., Brazil and Spain who shared their data
and experiences with us, including those who have been administering
Trappsol® Cyclo™ intravenously for more than five years."
CTD plans to engage with additional regulatory agencies in early
2016.
we do not care about VTESSE
please open a new board and post there everything about VTESSE
ok and why you delete my message???
lazarus is spamming!!!!!!
and the company pr. on 9/16
http://content.stockpr.com/ctdholdings/media/ab4649adb0bdbc9e6969b101f6692a26.pdf
http://content.stockpr.com/ctdholdings/media/ab54e17f75a8e01dc4153f8398e7d496.pdf
and here you are with the link
Actually is the update. 9/18 - 9/20
please find some interesting notes....i copy them from the pdf.
there are some graphs also but i don't know how to apload them here
2015 –Orphan Drug Designations transferred to CTD via its partner MNE from Sue French (for UK & Europe) and Caroline Hastings (US)
•Type II Drug Master File accepted by U.S. FDA
•August 2015: CTD announces plans for Intravenous Trappsol® Cyclo™ clinical trial and upcoming meeting with European health authority to discuss initiation of clinical program. 5
Goal: Gaining market approval for use of Trappsol® Cyclo® in the treatment of NPC
•Initial steps: 2013 –2015
•Established an expert team to develop/conduct the clinical program
•Dr. Sharon Hrynkow, first as consultant, now as Senior VP for Medical Affairs
•Accenture Accelerate R & D Services for Life Sciences
•Boyd Consultants --Alan Boyd
•AptusClinical
•KJC Statistics
•Prism Ideas
Why an Intravenous trial?
•NPC is a systemic disease
•Cyclodextrinsprovided to mice in a systemic manner lead to reduced total cholesterol, decrease in liver size, increase in longevity
•Following Slides courtesy of B. Liu, published data in A. Lopez et al, Clin. Exp. Pharm. Phys. 2014
Why an Intravenous trial?
•Anecdotal clinical data available for IV administration for up to five years
•Published reports on IV administration leading to stabilization of symptomology or improvements, including in CNS (“wakefulness”)
•IV less invasive than some other routes of administration
•IV easier for families and physicians to manage
•IV does not require sedation 13
When will the trial start?
Expected enrollment first half of 2016.
CTD’s cyclodextrin(Trappsol® Cyclo™) in use in 20 patients right now, and it has been in use in some for more than 5 years
•Trappsol® Cyclo™ has a consistent manufacturing process, a DMF as an Active Pharmaceutical Ingredient and has proven stability
•Anecdotal data suggest that an IV trial will be important for
NPC Patients and their Families
We are working to launch our IV trial in the first part of 2016
•Compassionate use programs will continue in parallel with clinical programs
•We look forward to working with the whole NPC community to improve the lives of NPC patients globally.
enjoy
"International Clinical Program Update" Presantation is out
Niemann-Pick –UK Conference
September 18 -20, 2015, WybostonLakes, UK
Sharon H. Hrynkow, PhD
Senior Vice President for Medical Affairs
unfortunately there is no link to provide
just a pdf on bloomberg terminal
very interesting presentation
CTD Holdings Closes $1.725 Million Private Placement
Investment Builds Company Strength in Preparation for Clinical Trials
http://finance.yahoo.com/news/ctd-holdings-closes-1-725-141635160.html
ALACHUA, FL--(Marketwired - July 22, 2014) - CTD Holdings, Inc. (OTCQB: CTDH), a manufacturer and distributor of cyclodextrins for the pharmaceutical, medical device, cosmetics, and other markets, announced today that it has closed on a Private Placement with a group of qualified private investors led by Novit L.P., an investment arm of U.S. Pharmacia.
The transaction involved the signing of a Securities Purchase Agreement under which CTD Holdings issued 1,725,000 shares of Common Stock at a price per share of $1.00, resulting in a $1,725,000 capital infusion to the Company. There were no other conditions connected to the issuance of the shares
any news from NY meetings???
maybe something positive from there???
I am just wondering...
when do you believe that the buy out will take place and how??
if someone have a few stock what happened to him???
do you know
what do you think