The US launch is approaching
CT001 launch under the Early Access program in the US is approaching
Timing
Both teams have been very busy preparing for the launch under the Early Access Program in the US - and this includes both the new manufacturing setup outside
Key events
Extensive planning and meetings have set the stage for a successful initial rollout, thus ensuring physicians understand the product, its profile and limitations and especially that patients have a positive experience. The first month is hence limited to selected states and hospitals before a wider distribution and promotion will take place. We will share more updates on the process after a few months on the market.
Packaging and design
Ventis Pharma is almost done with the final packaging, the brand name and design and we are eager to share this once the final quality assurance has been completed, as the perception testing was completed last month. This will always be important for a launch, even if it is an Early Access Program, and it becomes very real once this is final and ready to be shipped.
New patent application
Paediatric data to be published
Dental Study 0205 updates
In
Modelling and simulations in Children
We anticipate this important unified PK-PD model, developed based on all available both adult and paediatric study data (0201, 0204, 0205, and 0206), which are modelling and simulating exposure-response is to be published at the end of Q2 this year. This will have significant importance to the company, the regulatory process and later commercialisation of CT001.
For more information about
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com
About
http://publish.ne.cision.com//Release/ViewReleaseHtml/8D40AEF2071DEA95E0C856B0705FC7D6
https://mb.cision.com/Main/19921/3963597/2741731.pdf
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