In an earlier post I suggested that VCR would not receive approval to sell their VentrAssist in the US for another 8 years. I was rightfully challenged by Capman and others over my prediction as it flies in the face of what VCR have stated.
Although VCR have stated that they will commence their European pivotal trials in early 2004, gain CE Mark approval by the end of 2004 and start US pivotal trials/control group trials in 2004, IMO the following timing is a more likely scenario.
The European pivotal trial will not commence until the pilot trial in Australia is completed. Up to 10 implants will be performed in the pilot trial. The first implant was done on 28 June, the second implant has yet to be announced. Presuming that there is going to be a 1 to 2 month delay between implants, the pilot trial is not likely to be completed until the end of 2004.
After the completion of the pilot trial, allowing for a further month or so to evaluate the condition of the final implantee, VCR will have to present the pilot trial data to the European CE Mark regulators for their evaluation before granting permission to commence the pivotal trial. This process will take at least 12 months, so the pivotal trial is not likely to commence until the end of 2005.
The pivotal trial is to involve up to 30 patients. This trial is likely to take up to 2 years to complete and then probably another 12 months for the regulators to go through the data and consider the approval application. The CE Mark is likely to be obtained by the end of 2008.
VCR will now submit all trial data to the US FDA and make application for approval to commence US pivotal trials/control group trials. This approval will probably take 12 months allowing the US trial to begin at the end of 2009.
The US trial is to involve 55 to 63 implants with a control group of 50. This trial will likely take 2 years to complete and a further 12 months for the FDA to approve the device for sale in the US, this brings us to the end of 2012.
That is a little over 9 years down the track. Bring it back to 8 years to allow for any over estimations I've made in any of the regulatory processes.
The above estimations have not allowed for any delays that maybe encountered by patients dying, (that may require re-evaluations before continueing any trial), delays in having suitable patients at the right time, availability of medical teams in the required time frame and a whole host of other problems that could delay any of the process. Some of these problems could cause a further 1 to 2 years delay in the approval process.
It must be remembered that we are not talking about a production line process and all due care and precautions for the wellbeing of patients will be adhered to at all times.
I realise that my estimations are not likely to be well received by all and sundry, however the above is only my honest opinion after researching other implant trials and the regulatory processes that have to be adhered to.
I welcome any critisms and appraisals of my assumptions, providing that they are made in the same spirit that I have made those assumptions, in good faith.
Seaking___________________estimating
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