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https://legiscan.com/TX/bill/HB3948/2021
Adjournment sine die (from the Latin "without day") means "without assigning a day for a further meeting or hearing". To adjourn an assembly sine die is to adjourn it for an indefinite period. A legislative body adjourns sine die when it adjourns without appointing a day on which to appear or assemble again.
It can be used in reference to United States legislatures whose terms or mandates are coming to an end, and it is anticipated that this particular body will not meet again in its present session, form, or membership.[3] A legislative body adjourned in this way may be called back into special session, a reason why sine die adjournment rather than dissolution may be preferred in some cases.
Ricky, if you are so worried about the stock price, why not do a little more buying and a little less whining!
Ricky, the Q’s come after the P’s and before the R’s. Please reference the link below!
https://www.k12schoolsupplies.net/Cursive-Chart-p/tcr7688.htm?gclid=EAIaIQobChMIuuLkot2t8AIVYm1vBB201w-JEAQYAyABEgL2tfD_BwE&click=9
Ricky have you counted the number of references to RTON’s tweet that have occurred outside of the Twitter sphere. An example would be the reference you just made on IHUB. Does that not count?
Yes Bobby, I am quite proficient in Google Maps, as I have set the example for you in post # 13242. Now, using said example and in an effort to help you explain yourself better, you should reciprocate by posting the ‘none’ Dalrock Rd retail shop of which you have lamented. Your post should contain a single link, again feel free to use the example in post # 13242 as a guide. Upon doing such, the community can better understand the setting for which you have lamented! Capiche?
Understand the tools you are using! See link below! Zoom out and take a larger look....Bobby! Plenty of residential nearby! You remind me of person that could never refold a paper map!
https://www.google.com/maps/place/6501+Dalrock+Rd+%23100,+Rowlett,+TX+75089/@32.9184217,-96.5197703,626m/data=!3m1!1e3!4m13!1m7!3m6!1s0x864c02723a21dc2d:0x81d012082172f092!2s6501+Dalrock+Rd+%23100,+Rowlett,+TX+75089!3b1!8m2!3d32.918564!4d-96.5185918!3m4!1s0x864c02723a21dc2d:0x81d012082172f092!8m2!3d32.918564!4d-96.5185918
FDA to propose ban on menthol-flavored cigarettes, with industry likely to challenge
If the FDA ban does not extend to Hemp products (i.e. ENDO TOKES) this may be a win for RTON
https://endobrands.com/collections/endo-smokables/products/endo-tokes-menthol
https://www.cnbc.com/2021/04/29/fda-to-propose-ban-on-menthol-flavored-cigarettes.html
Who are these experts you reference?
Synonym: “people aren’t stoked for Ric anymore?”
A short period of time will pass.....
Attach a date or time frame to your statement, otherwise the statement is frivolous!
Based on the news release this stock should start climbing in anticipation of the 10Q's and therein lies the answer to the 1200% sales increase in real terms as opposed to relative...
Grisaffi also noted, "We have filed our 10-K today on our quest to becoming a fully reporting company again with the SEC. This was a long and costly process and time consuming. Now our accountants and auditors will be completing the quarterlies and we believe that this process will be completed by the end of April or sooner."
You mean the 10-Q
Careful Ricky, the situation may be bigger than you think?
https://media2.giphy.com/media/fjxOktMff1aZ5Drxhe/giphy.gif
50,000,000 million shares is NOT equal to 50,000,000 shares!
50,000,000 shares = 50 million shares…….Ok Ricky??
Your statement “management said RS read the news.” Purposely interjects ambiguity and implies that a reverse split is fact and forth coming, when it is NOT! Nice try...
Nope! re-read.....
In the absence of a PR the stock price is trending down but sales are presently trending up by 1200%
TREND! Hello......
It is the positive trend that is being conveyed here, why is that so difficult to understand?
By analogy, if these statements were made the trend would be intuitively obvious!
Cars prices are up 1200%
Rental property prices jumped 1200%
Had RTON stated that sales were down by 1200% would you still need to see
the absolute numbers? Or would you understand that trend to be negative?
This stock price is PR driven and until RTON is SEC compliant, forget about numbers just and follow the tend!
Where? When?
If that were the case, why not release another PR and cash in on the price spike?
Ordered on Feb 23, received email & text message at 12:07 am on Feb 27 stating order is on the way! Tracking number was included!
Study on cannabis chemical as a treatment for pancreatic cancer may have 'major impact,' Harvard researcher says
Pancreatic cancer makes up just 3 percent of all cancers in America. But with a one-year survival rate of just 20 percent (and five-year survival rate of less than 8), it’s predicted to be the second leading cause of cancer-related death by 2020.
Headlines about the illness, as a result, tend to be discouraging. But this month scientists from Harvard University’s Dana-Farber Cancer Institute have released some much-needed good news. In their study, published in the journal Frontiers of Oncology on July 23, the researchers revealed that a chemical found in cannabis has demonstrated “significant therapy potential” in treatment of pancreatic cancer.
The specific drug, called FBL-03G, is a derivative of a cannabis “flavonoid” — the name for a naturally-occurring compound found in plants, vegetables and fruits which, among other purposes, provides their vibrant color. Flavonoids from cannabis were discovered by a London researcher named Marilyn Barrett in 1986, and were later found to have anti-inflammatory benefits.
But while scientists long suspected that cannabis flavonoids may have therapeutic potential, the fact that they make up just 0.14 percent of the plant meant that researchers would need entire fields of it to be grown in order to extract large enough quantities. That changed recently when scientists found a way to genetically engineer cannabis flavonoids — making it possible to investigate their benefits.
Enter the researchers at Dana-Farber, who decided to take the therapeutic potential of one of these flavonoids, FBL-03G, and test it on one of the deadliest cancers through a lab experiment. The results, according to Wilfred Ngwa, PhD, an assistant professor at Harvard and one of the study’s researcher, were “major.”
“The most significant conclusion is that tumor-targeted delivery of flavonoids, derived from cannabis, enabled both local and metastatic tumor cell kill, significantly increasing survival from pancreatic cancer,” Ngwa tells Yahoo Lifestyle. “This has major significance, given that pancreatic cancer is particularly refractory to current therapies.”
Ngwa says that the study is the first to demonstrate the potential new treatment for pancreatic cancer. But on top of successfully killing those cells, the scientist found FBL-03G capable of attacking other cancer cells — which was startling even to them. “We were quite surprised that the drug could inhibit the growth of cancer cells in other parts of the body, representing metastasis, that were not targeted by the treatment,” says Ngwa. “This suggests that the immune system is involved as well, and we are currently investigating this mechanism.”
The significance of that, says Ngwa, is that, because pancreatic cancer is often diagnosed in later stages, once it has spread, and the flavonoids seem to be capable of killing other cancer cells, it may mean the life expectancy of those with the condition could increase.
“If successfully translated clinically, this will have major impact in treatment of pancreatic cancer,” says Ngwa.
The next step for the Harvard researchers is to complete ongoing pre-clinical studies, which Ngwa hopes will be completed by the end of 2020. That could set the stage for testing the new treatment in humans, opening up a new window of hope for a group long in need of it.
Overview of the IND Process
Joyce L. Frey
Acting Deputy Office Director Office of Cellular, Tissue, and Gene
Therapies
CBER 101 – An Introduction to CBER March 22-24
Gaithersburg, MD 1
• Statutes – enacted by Congress
• Public Health Service Act
• Food Drug & Cosmetic Act
• Regulations – binding interpretations of law
• Code of Federal Regulations (CFR)
• 21 CFR 312 – Investigational New Drug Application (IND)
• Guidance – describes agency’s policy & regulatory approach to a specific area or issue
• Not binding on industry, but usually binding on agency
Phases of Investigation
(21 CFR 312.21)
• Phase I Investigational Studies
• Designed to evaluate safety and side effects
• Phase II Investigational Studies
• Designed to evaluate efficacy and dose ranging
• Phase III Investigational Studies
• Expanded study, additional information on efficacy and safety
• Biologics License Application (BLA)
Phases of Investigation (Cont.)
• Can begin studies at any phase
• e.g., If studies already conducted in other countries, previous studies can support initial submission of a Phase 2 or 3 study, or BLA.
• May skip a phase
• e.g., If you perform a Phase 1 study, and have appropriate results it is possible to proceed directly to a Phase 3 study.
• Request must be submitted in writing (fax is fine) and should include:
• Description of product
• Description of clinical indication and approach
• Identification of purpose, objectives, and draft of specific questions
• Suggested dates and times for meeting
• Pre-IND meetings are scheduled within 60 days from receipt of request
• FDA will respond to request within 14 days of receipt of request
• Meeting package must be submitted 4 weeks prior to meeting, includes:
• Pre-clinical data
• Product manufacturing scheme
• Data regarding product characterization/proposed specifications
• Proposed clinical protocol
• Specific questions grouped by discipline (product, pre-clinical, clinical)
• One hour formal meeting held by telephone unless unique situation.
• FDA issues official minutes to applicant within 30 days of formal meeting.
• Other meetings which may take place during the life-cycle of an IND include:
• End of Phase 1 meetings (21 CFR 312.82)
• End of Phase 2/Pre-phase 3 meetings (21 CFR 312.47)
• Pre-BLA (Biologics Licensing Application) meetings (21 CFR 312.47)
• For more information, please see “Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products”
• Submit in triplicate if paper submission
• If electronic submission, no hard copies are needed
• http://www.fda.gov/cber/gdlns/eind
• Address for submission
CBER/(Appropriate Office)
Attention: Regulatory Management Staff HFM-99, Room 200 north
1401 Rockville Pike
Rockville, MD 20852
• Cover Sheet - Form 1571
• Identifies sponsor, investigational drug, phase of investigation, parties responsible for monitoring conduct of trial
• Found at http://forms.psc.gov/forms/FDA/fda.html
• Table of Contents
• Introductory Statement & General Investigational Plan
• Investigator’s Brochure
• Required if product is supplied to clinical investigators other than the sponsor
• Protocol for each planned study
• Chemistry, Manufacturing, and Control Information
• Pharmacology and Toxicology Information
• IRB Approved Consent Form
• Previous Human Experience
• Additional Information
• Cross-reference authorization letters
• Form 1572
• Signed statement by each investigator containing their contact & IRB information, and agreement to conduct study following regulations
• Found at http://forms.psc.gov/forms/FDA/fda.html
• Number Pages
• Alternative mechanism for submission of product & manufacturing information
• Does not include clinical protocol
• Permits holder to incorporate the information by reference when submitting an IND or
• To authorize other persons to reference information, without direct disclosure
• FDA accesses MF via cross-reference letter submitted to MF and IND
• Letter obtained from MF holder
• FDA reviews MF only when IND cross- referencing it has been submitted
• MFs are neither approved or disapproved
• However, a cross-referencing IND may be placed on hold due to deficiencies in a MF
• IND number is assigned
• Regulatory Project Manager (RPM) receives IND submission.
• Handles administrative processing of IND
• Issues acknowledgment letter
• Titles IND based on final product administered to patient
• Serves as regulatory contact
• Obtains review team assignments.
• IND routed to reviewers for review
• Review team includes:
• Regulatory Project Manager
• Product Reviewer
• Pharmacology/Toxicology Reviewer
• Clinical Reviewer
• Statistical Reviewer
• If product includes a device or drug, consult reviewers from CDRH or CDER are assigned if needed, during initial processing.
• During first 30 days – review ongoing
• Communication with sponsor
• clarification
• resolution of issues
• Facsimilies
• Used to make review decisions
• Not official documents and not filed in an IND application – must be followed up with official hard copy submission
• E-mail
• Outlook is not a secure email system
• Can set up secure email with the agency
• Within 30 days, IND goes into effect or is placed on clinical hold
• 30-day review clock based on date of receipt in FDA
• Decision is communicated by telephone
• If IND is placed on hold, a detailed letter is issued within 30 days of hold telecon
• If IND is allowed to proceed, a detailed letter is issued only if there are additional non-hold requests for information
Clinical Holds (21 CFR 312.42)
• Hold: An order issued by FDA to delay a proposed clinical investigation or to suspend an ongoing investigation
• Once active, an IND may be placed on hold if the grounds listed under 21 CFR 312.42(b) are met
• Partial Hold: A delay or suspension of part of the clinical work under an IND
• e.g. IND has 2 protocols, one may proceed & one may not
Response to Hold
• Upon receipt of an amendment entitled “Complete Response to Hold”
• RPM sends email alerting reviewers to the response and the due dates.
• The reviewer must immediately evaluate the submission to determine if the response is complete.
• If response addresses all issues detailed in hold letter, response is considered complete, and FDA must respond, in writing, within 30-days of receipt of the submission.
• 30-day clock does not apply to partial or incomplete responses.
• FDA either allows study to proceed (remove hold) or continues the hold (response was complete, however inadequately addressed issues).
• For more information please see Guidance for Industry: Submitting and Reviewing Complete Responses to Clincial Hold and CBER SOPP 8201 – Issuance of and Response to Clinical Hold Letters for IND applications, found at
http://www.fda.gov/cber/regsopp/8201.htm.
IND Amendments
• Any document, from the sponsor, in support of the IND
• Must be submitted in hard copy
• In triplicate for INDs
• Duplicate for Master Files
Annual Reports (21 CFR 312.33)
• Every year, within 60 days of the anniversary date that your IND went into effect, including:
• Individual study information
• Summary information
• Description of the general investigational plan for the coming year
• Any revisions to the investigators brochure
• Any significant protocol modifications
• Foreign marketing development
• Any outstanding business
• If we do not receive an annual report, FDA may issue the following letters:
• Report Request Letter (RR)
• Pretermination Letter (PT) if the sponsor does not reply within 30-days of the RR letter.
• Termination Letter if the sponsor does not reply within 30-days of the PT letter.
• Inactivated: IND is subject to no activity, but may be reactivated (21 CFR 312.45).
• Withdrawal: Sponsor requests to end IND, IND cannot be reactivated (21 CFR 312.38).
• Terminated: FDA orders sponsor to end all clinical investigations, IND cannot be reactivated (21 CFR 312.44).
• Exempt: Study does not have to be conducted under IND.
• May be performed at request of sponsor or by FDA if certain conditions are met.
• FDA may inactivate if IND on hold for over 1 year.
• Once inactive for 5 years, FDA may terminate the IND.
• FDA may inactivate if no subjects are entered into clinical studies for 2 years or more.
• Sponsors not required to submit annual report to inactive IND; however,
• IND still in effect for purposes of public disclosure of information & data under 21 CFR 312.130.
• In general, inactive INDs cannot be cross-referenced.
• Reactivation may occur with submission of new protocol, updated manufacturing information, etc.
• Subject to 30 day review clock
• For gene therapy INDs, sponsor should inactivate rather than withdraw based on requirements for long-term patient follow up.
• Retroviral INDs have life-long patient follow-up.
• Adenoviral INDs have 15 year patient follow-up.
• At any time a sponsor may withdraw an IND without prejudice.
• All trials must be ended. These are dead files that cannot be resuscitated; sponsor must submit new IND.
• Withdrawn INDs cannot be cross- referenced.
• FDA does not recommend that sponsors submit information to withdrawn files. Submissions to withdrawn INDS are not tracked by DCC or RPM.
• Termination is initiated by FDA and must be preceded by a proposal to terminate & an opportunity for the sponsor to respond.
• In general FDA doesn’t terminate INDs but works with the sponsor to correct deficiencies.
• Most commonly used when IND has been inactive for more than 5 years.
Emergency Use of an IND
(21 CFR 312.36)
• Occurs when need for an investigational drug arises in an emergency situation that does not allow for the submission of a complete IND.
• e.g., patient has few months to live.
• For treatment of 1 patient, cannot be turned into an IND to treat multiple patients.
• Not subject to 30-day clock; however, sponsor must submit all information within 30 days.
Information on IND Submissions
• Request CBER IND Packet:
• Office of Communication, Training, and Manufacturers Assistance (OCTMA) (301) 827-2000 or http://www.fda.gov/cber/ind/ind.htm.
PMCB Making more progress in the fight against diabetes. They are working to develop Melligen cells .These are human liver cells that have been genetically engineered to produce, store and release insulin.
PMCB is working to treat acute cancers or ones that don’t have much mainstream therapy. The drug delivery platform being created this company will positively change the landscape in patient treatment!
PMCB is making serious progress in the fight against Cancer with a focus on pancreatic cancer. 95% mortality rate once diagnosed. One of the most aggressive cancers. Great progress so far!
Bingo!
PharmaCyte’s partner, Austrianova, has successfully encapsulated the live cells used in PharmaCyte’s therapy for its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC)
PMCB is making more progress in the fight against diabetes. They are working to develop Melligen cells. These are human liver cells that have been genetically engineered to produce, store and release insulin.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no treatment related side effects.
The drug delivery platform being created by PharmaCyte Biotech could greatly change the landscape for cancer treatment and beyond!
With a wave of groundbreaking products in the pipeline, biotechnology could be poised to keep churning higher for the foreseeable future.I am excited about the potential of this stock because Cancer has become one of the biggest killers of the modern age. More than 600,000 Americans die of cancer each year, according to the American Cancer Society. We need a solution.
Right now, PharmaCyte Biotech (PMCB) is putting together the necessary material for its planned clinical trial for inoperable pancreatic cancer, one of the most deadly forms of cancer today.
Agreed! Its drug delivery technology could change the way countless diseases could be treated and it starts with the "box" concept! This will be big!