Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > Hemerion Planning Phase 2 Trial at Mt. Sinai NY in 2022

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Comment by Eoganachton Nov 24, 2021 5:16pm

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Post# 34163313

RE:RE:RE:RE:RE:RE:RE:RE:Hemerion Planning Phase 2 Trial at Mt. Sinai NY in 2022

I hope you're right, and you probably are, but the vagueness of the wording from the European Medicines Agency makes me uneasy.

"Orphan medicines benefit from ten years of market exclusivity once they receive a marketing authorisation in the European Union (EU). This measure is intended to encourage the development of medicines for rare diseases, by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period."

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/orphan-medicines/market-exclusivity-orphan-medicines

"On 12 January 2017, orphan designation (EU/3/16/1811) was granted by the European Commission to Centre Hospitalier Universitaire de Lille, France, for 5-aminolevulinic acid for the treatment of glioma."

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/orphan-medicines/market-exclusivity-orphan-medicines

enriquesuave wrote:
Im not sure Theralase would be in direct competition as Rutherin would probably be used with X-ray activation instead of surgery or both light and X-ray activation with only small cranial incisions to place fibre optics, also instead of surgery. Hemerion is working on an intra operative procedure which would be done right at the end of surgery for GBM tumors. So different indications and no worries for Orphan Status. All IMHO

Eoganacht wrote: What would be crazy would be if Hemerion accomplishes their aim of attaining marketing authorization for ALA for glioma in Europe by 2026 and is granted confirmation of their orphan status and Theralase comes out with a much better FDA approved treatment a couple of years later. Would Theralase be frozen out of the European glioma treatment market because Hemerion is protected from competition for ten years from a similar medicine for a similar indication?

fredgoodwinson wrote: Not sure that it works like that.