Oggetto/Subject: EMA Application ASAP - Be a turning point in the trajectory of the ALS/MND
To the kind Attention of Mr Raj Meha - CEO Seelos Therapeutics
Dear Mr. Raj Meha,
time is a luxury that no sufferer can afford, especially an ALS sufferer.
This is why I am writing to you today on my behalf, but I am sure to share the same needs and the same hope as the whole community of thousands of patients with Amyotrophic Lateral Sclerosis, to beg you to accelerate with all your determination the development of your treatment for ALS.
On April 29th, a meeting between representatives of ALS patients from some European countries and a team from the European Medicines Agency took place to talk about ALS and how clinical trials are carried out.
On the part of the EMA there were:
Pavel Balabanov - Pavel.Balabanov@ema.europa.eu
Head of Therapies for Neurological and Psychiatric Disorders Office
Iordanis Gravanis - Iordanis.Gravanis@ema.europa.eu
Head of Scientific Advice Office
Kristina Larsson - Kristina.Larsson@ema.europa.eu
Head of Orphan Medicines Office
The meeting brought to light the Agency's willingness to collaborate side by side with companies that develop drugs and treatments for ALS: in particular, the agency is available to help companies review data - when shared.
Furthermore, given the criticality of this disease, it has been reiterated that if there was even a small evidence of benefit deriving from an experimental treatment, the agency would be happy to quickly assess the data to allow accelerated access to treatment.
In light of the above, I respectfully urge you to immediately contact the European Medicines Agency to try to request at least a Conditional Marketing Authorization allowing you to continue the further steps in your clinical trials.
Considering that the last phase of your trial had a treatment period of less than 12 months, you may have some concerns in contacting the EMA, nevertheless it is important to clarify that you can still approach the EMA (for scientific advice or eventually a marketing authorization application) even if you have conducted a study shorter than 1 year duration.
EMA is open to dialogue: you would need to provide evidence to support your decision related to the duration of the trial. There is no selection based on the length of the trial.
Accelerated Assessment and Conditional Marketing Authorization - in addition to the support of the Scientific Advice Team - are all tools you can use to reduce the time to market of your experimental treatment, giving hope to thousands of ALS patients who need to slow down or hopefully stop the progression of this terrible disease while waiting for a definitive cure.
You, your company, your team and your drug can represent a turning point in the lives of thousands of people and thousands of families, children, grandchildren, brothers, cousins, sisters, grandparents, mothers and fathers who live looted lives from every dream or hope and who cannot imagine a happy future.
Be a turning point, be a game changer.
Have the courage to save the lives of thousands of people.
Sincerely yours,
(EMAIL ADDRESSES "To")
(EMAIL ADDRESSES "Cc")
