Friday, May 17, 2024 7:26:29 PM
Once DCVax-L is in use in the NHS, there is no legal reason to prevent a competent doctor from adding in poly-ICLC to the DCVax-L treatment even though the poly-ICLC, by itself or in combination, has not been formally tested in a clinical trial for GBM, is not licenced by the MHRA and is not endorsed by NICE. Of course there are provisos for going off-licence: 1] the NHS would not pay for the poly-ICLC (but a 2 week course might be anywhere between $500 - $2,000 [ChatGPT]); 2] the Doctor would have to take full responsibility for what he is doing and would have to satisfy several conditions or run the risk of a penalty, up to and including manslaughter and/or striking off should he be found to have disregarded the guidelines or acted recklessly. This will be adjudged by whether he was acting in line with the following [ChatGPT]:
1] Clinical Justification: The prescriber must have a strong clinical justification for using an unlicensed medication. This typically occurs when no licensed alternative is available or when the licensed alternatives have been ineffective or unsuitable for the patient.
2] Informed Consent: The patient (or their legal guardian) must be fully informed about the unlicensed status of the medication, the reasons for its use, potential risks, and any available alternatives. Informed consent should be obtained and documented.
3] Professional Responsibility: The prescribing clinician assumes full responsibility for the decision to use an unlicensed medication and its outcomes. They must ensure that they are acting in the patient’s best interest and that they have sufficient knowledge about the medication and its effects.
4] Guidance and Recommendations: Organizations such as the General Medical Council (GMC) and the British Medical Association (BMA) provide guidelines on the circumstances and conditions under which unlicensed medications can be prescribed. These guidelines emphasize patient safety, thorough documentation, and clinical necessity .
5] Special Situations: Unlicensed prescribing is more common in certain fields such as pediatrics, oncology, and rare diseases where licensed treatments may not exist or are insufficient.
6] Regulatory Framework: While the MHRA oversees the licensing of medications, it also acknowledges that off-label and unlicensed prescribing can be essential in clinical practice. Therefore, it provides a regulatory framework within which such prescribing is permissible under the aforementioned conditions. [end ChatGPT]
If physicians see from the preliminary studies already done that poly-ICLC significantly boosts the efficacy of DCVax-L with little or no increase in toxicity and that it is within a reasonable price range for their patients (who will not now have to fund the whole of their DCVax-L treatment), it will soon become blindingly apparent that the combination is a highly effective treatment for GBM. The MHRA will then be hard pressed not to give it their (perhaps temporary and conditional) blessing even if they demand that those treated form part of an open trial using the Phase 3 study (as per the NY Academy of Science Journal) as the "historic comparison" group.
Recent NWBO News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
DaBaby and Stunna 4 Vegas's "NO DRIBBLE" Joins Music Licensing, Inc.'s Portfolio • SONGD • Jun 7, 2024 10:15 AM
Mushrooms Inc. (OTC: MSRM) Announces Significant Share Buy Back by the Board Director and New Strategic Initiatives. • MSRM • Jun 5, 2024 1:32 PM
Hydromer Announces Launch of HydroThrombX Medical Device Coating Technology • HYDI • Jun 5, 2024 10:24 AM
Dr. Michael Dent Finances $1 Million to Drive HealthLynked's Healthcare Transformation • HLYK • Jun 5, 2024 8:00 AM
Avant Technologies Enters Binding LOI to Purchase Dozens of High-Performance, Immersible, AI-Powered Servers • AVAI • Jun 5, 2024 8:00 AM
IQST - iQSTEL Announces $290 Million 2024 Annual Revenue Forecast • IQST • Jun 4, 2024 1:43 PM