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11:56
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Originally posted by moneydown:
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BSI is the consultant for CE mark - Oncosil reported that must have paid extra to use their fast track services a year or more ago - what they have been doing with Oncosil is unknown in terms of why this has all taken so long to come back finally with a rejection - I would be asking Oncosil of their opinion of BSI - and whether they should continue with their services seems not to have helped the position for any of us. Personally Oncosil should cut their losses with BSI and look for a new firm to represent them - using an Australian office to communicate with a backlog of devices in the EU may be part of the problem. Possibly they should choose a boutique firm based in Europe. While BSI has many offices it may be that you want a smaller group more focused solely based in Europe to push the agenda. I would also consider the regulatory documents and look at other areas to file such as the TGA or Singapore - at least they can generate regulatory data that could be used to support an EU re-submission. At least that would give the market some confidence. They could also try a fast track solution in Korea. There are many options to give some positive news to the market - being stubborn on Europe and hitting the share price does not do anyone any good. I am a long time hold but now I am frustrated. Possibly it is a time to buy back in if the price goes lower. There are many other examples where companies took a slide and bounced back but they need a new strategy.
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BSI is not a consultant to anyone. BSI is a competent authority (MHRA) approved issuer of EC certs. Their job is to ensure timely patient access to medical devices with demonstrated safety, efficacy and clinical benefit. And they do an excellent job.
