Medlab Clinical eyes cost savings following receipt of SME status in Europe
Medlab Clinical Ltd’s (ASX:MDC) European subsidiary has received formal SME (small or medium-sized enterprise) qualification from European Medicines Agency (EMA).
EMA is the European equivalent to the Australian TGA and the US FDA. As part of the registration, this allows MDC to apply for scientific advice, drug evaluation and registration of NanaBis.
It also provides MDC with the opportunity to obtain fee reductions up to 90% in the process.
NanaBi is a cannabis-based medicine which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).
Medlab chief executive officer Dr Sean Hall said: “This is a significant milestone for MDC. Drug registration of NanaBi is key part of the company’s plans and this qualification allows us to start the process into Europe.
“Drug evaluation and registration fees with the various agencies are expensive, but at the same time, a much needed and real cost in bringing a drug to market and we welcome the opportunity obtain fee reductions and as a result significant savings.
“Personally, I would like to thank EMA for their collaborative approach in this regard, and very much look forward to escalating the NanaBis evaluation with EMA as we move closer to an approved drug in the EU.”
READ: Medlab Clinical proceeding to stage 2 for cannabis cancer trial
In late October 2018, Medlab successfully completed stage 1 of the NanaBis human trial on cancer patients at Royal North Shore Hospital.
The trial is progressing as planned and currently in stage II of the ethics approved trial.
READ: Medlab Clinical receives preliminary results from NanoStat™ trial Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/212744/medlab-clinical-eyes-cost-savings-following-receipt-of-sme-status-in-europe-212744.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).