Dcab
2 meses hace
What are the benefits of being awarded orphan drug status?
There are many benefits to having ODS. In addition to eligibility for grant funding, regular input from the OOPD, and qualification for rapid FDA approval processes, other benefits include:
Prescription Drug User Fee Act (PDUFA) exemption: In 1992, the U.S. Congress created the PDUFA, which allowed the FDA to collect fees from manufacturers. The fees are important in speeding up the medication approval process. However, if the manufacturer obtains ODS, the FDA will waive the NDA or BLA application fee, which can be over $2 million.
Orphan drug tax credit: The manufacturer receives a tax credit for a percentage of qualified study costs.
Market exclusivity: The manufacturer won’t have to worry about competition on the market for 7 years.
Free pricing: The manufacturer will have the freedom to set any price on the OD.
Penny Stocks 2.0
2 meses hace
$OTLC Monster $27.6M Cash Deal, $50,000,000 Deal coming Plus IPO »» Oncotelic’s joint venture (JV) with Dragon Overseas Capital Limited, an affiliate of Golden Mountain Partners, LLC. The JV initial focus is on the development and commercialization of OT-101, the transformative cancer drug that Oncotelic licensed to the JV for a 45% ownership. Dragon Overseas invested cash of $27.6 million for a 55% ownership of the JV.
The JV is planned to be headquartered in Hong Kong. Oncotelic could potentially receive up to $50 million following the sale of the RPD voucher once OT-101 has received marketing approval for diffuse intrinsic pontine gliomas. The JV is expected to launch an initial public offering (IPO) on the Hong Kong Stock Exchange in 2024, and CEO Dr. Vuong Trieu has said he expects the IPO to be highly successful.
Penny Stocks 2.0
2 meses hace
$OTLC HUGE RIGHT HERE » The Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”), for various cancers
Who's the Joint Venture Partner DRAGON CAPITAL OVERSEAS
Dragon Capital Group, an investment platform that focuses on Vietnam and other emerging Southeast Asian markets, has $6.1 billion in assets under management (AUM) as of March 31, 2024.
Our portfolio features two flagship funds: the Vietnam Enterprise Investments Limited (VEIL), a closed-end fund with over $1.8 billion AUM and listed on the London Stock Exchange
Who's the Affiliated Partner GREAT MOUNTAIN PARTNERS
Great Mountain Partners (GMP) is a private markets investor with $10 billion in assets under management. GMP's portfolio includes companies in sectors such as media and entertainment, transportation, energy, infrastructure, and financial services.
Penny Stocks 2.0
2 meses hace
Must Buy $OTLC Medical Research Gem
Last week they submitted PHASE 3 Clinical Trial Results to the #FDA for Oncotelic OT-101 against Metastatic Pancreatic Cancer - First in Class!!
Price Target $4.00 by Litchfield Hills Research otcmarkets.com/research-repor…
Amazing Pipeline ... oncotelic.com/pipeline/
Last week the CEO PURCHASED 500,000 shares at $0.02. He Purchased Almost $50,000 or 1.8m shares on the open market.
The AUDITED FINANCIALS Show Almost $30,000,000 in Assets
They just signed a Deal (8-k Signed) for $45,000,000 with another Company. $15,000,000 Cash and $30,000,000 in Shares
otcmarkets.com/filing/html?id…
Market Cap is only $10m Phase 3 Clinical Trials, it should be $100,000,000 or more easily.
They opened a state-of-the-art GMP Manufacturing Plant, a significant stride in biopharmaceutical innovation, through its joint venture Sapu Biosciences LLC Situated in San Diego biotechnology hub, this cutting-edge, AI-driven facility marks a pivotal expansion in the company's clinical pipeline, advancing beyond its OT-101 development. Discover more at sapubio.com/contact/."
An IPO is coming
This will be the second transaction for capitalizing on our assets and building shareholder value. The first being the successful transition of OT-101 to our joint venture (“JV”) with Dragon Capital Overseas, Limited. The JV is expected to list for an IPO, as well as the completion of establishing a research and manufacturing facility headquartered in San Diego, California." expressed Dr. Vuong Trieu, CEO of Oncotelic
#AITechnology
#MedicalResearch #Cancer #CureforCancer #Pancreatic #Biotechnology
Penny Stocks 2.0
2 meses hace
$OTLC Huge 8-K $45,000,000 Deal Right here
As per the terms contained in the Term Sheet, Mosaic will pay Oncotelic $15 million in shares upon the closing of a definitive agreement for certain pre-agreed indications of CA4P. In addition, Oncotelic may earn upto $15 million in cash and $15 million in shares of Mosaic, upon achievement of certain agreed upon milestones. Additional terms of the Term Sheet include that (1) Mosiac to continue the development work necessary to achieve the mutually agreed upon milestones which will include an annual budget of $2.0 – $2.5 million,
https://www.otcmarkets.com/filing/html?id=17484592&guid=gVL-kaSFt2dfJth
Penny Stocks 2.0
2 meses hace
OTLC must read This was $0.25 not long ago...
Price Target is $4.00+ by the Experts, not me.
So the CEO PURCHASED shares $10,000 at .02 last week, exactly when they submitted the PHASE 3 CLINICAL TRIAL RESULTS to the #FDA
They have over $30,000,000 in Assets Plus $15,000,000 in shares of $CPMV plus $15,000,000 more to come.
Realistically that's $60,000,000 in Assets with a $$10m Market Cap
IF The FDA APPROVAL is met, the revenue with be astronomical and there's huge BUYOUT Potential at stake..
Re: Submission of Clinical Trial Results Information Pursuant to 42 U.S.C. 282(j)
FDA Reference Number: CDER-2024-145
NCT02641639
Penny Stocks 2.0
2 meses hace
$OTLC .026 MONSTER FIND SUBMISSION OF PHASE 3 CLINICAL TRIAL RESULT U.S. FOOD & DRUG ADMINISTRATION
VIA UNITED PARCEL SERVICE AND E-MAIL
Oncotelic Therapeutics, Inc.
Attention: Larn Hwang, Ph.D., Chief Scientific Officer
29397 Agoura Road, Suite 107
Agoura Hills, California 91301
Re: Submission of Clinical Trial Results Information Pursuant to 42 U.S.C. 282(j)
FDA Reference Number: CDER-2024-145
NCT02641639
Dear Dr. Hwang:
Based on an initial review of Food and Drug Administration (FDA) records, information from
the ClinicalTrials.gov data bank operated by the National Library of Medicine, a part of the
National Institutes of Health, and any available public information, it appears that Oncotelic
Therapeutics, Inc. (formerly Mateon Therapeutics, Inc.), is the “responsible party”1 for the
above-identified clinical trial, which appears to be an “applicable clinical trial”2 subject to the
requirements of section 801 of the Food and Drug Administration Amendments Act of 2007,
including its implementing regulations in 42 CFR part 11. A responsible party for an applicable
clinical trial is required to submit to the ClinicalTrials.gov data bank certain results information
for the clinical trial; such results information generally must be submitted no later than one
year after the primary completion date3 of the applicable clinical trial, unless the responsible
1 See sections 402(j)(1)(A)(ix) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(1)(A)(ix)) and 42 CFR
11.10 for the definition of “responsible party.” We recognize that Mateon Therapeutics is listed as the
responsible party for this clinical trial in ClinicalTrials.gov data bank. However, public records show that Oncotelic
Therapeutics, Inc., merged with Mateon Therapeutics, Inc. (https://www.biospace.com/article/releases/oncotelic-
therapeutics-inc-formerly-mateon-therapeutics-inc-name-and-symbol-change-/). Accordingly, Oncotelic
Therapeutics, Inc., appears to be the responsible party for this clinical trial. 2 See sections 402(j)(1)(A)(i)-(iii) of the PHS Act (42 U.S.C. 282(j)(1)(A)(i)-(iii)) and 42 CFR 11.10 for the
definition of “applicable clinical trial.” 3 See 42 CFR 11.10 for the definition of “primary completion date.” See also section 402(j)(1)(A)(v) of the PHS
Act (42 U.S.C. 282(j)(1)(A)(v)), which defines “completion date.” As reflected in 42 CFR 11.10, the terms
“primary completion date” and “completion date” are synonymous for the purposes of 42 CFR part 11.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
Reference ID: 5444521