RE: Serious buying20 Oct 2016 21:30
Never said there wasn't 'potential' potentially.
Your way off on your estimates to get Episalvan to market.
Excerpts from the European approval..
The last part is not exactly a ringing endorsement!
What benefits of Episalvan have been shown in studies?
Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in
patients who underwent skin graft surgery. The patients received Episalvan together with wound
dressing on one half of the wound, while the other half of the wound was treated with standard wound
dressing only. In the first study, the average time from surgery to wound closure was 17.1 days for
the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with
Episalvan. The respective times were 16.0 and 15.1 days respectively in the second study.
A third study involved 57 patients with partial-thickness burn wounds who had half their wound treated
with Episalvan and the other half with a standard disinfectant gel. Both wound halves were also
covered with a wound dressing. The average time to wound closure was 8.8 days for the wounds
treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan.
What are the risks associated with Episalvan?
The most common side effects with Episalvan are wound complications, pain in the skin (both of which
may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people).
For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet.
Why is Episalvan approved?
Episalvan gel was shown to reduce wound healing times. Although the differences were small they
were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and
for which treatment options are limited. With regard to safety, no major issues were identified and side
effects were manageable. The Agency’s Committee for Medicinal Products for Human Use (CHMP)
therefore decided that Episalvan’s benefits are greater than its risks and recommended that it be
approved for use in the EU.