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rtg123

09/28/20 11:29 AM

#128868 RE: Paulness #128866

I don't expect to hear much until after the IDE pre-submission meeting with the FDA. Korenko and Co will be busy preparing for the meeting which will require submission of background material and include the preliminary results from the biocompatibility testing. I have been involved in similar meetings with the FDA and it will take them time and careful preparation to ensure a productive discussion and set the stage for a successful IDE submission. The good thing is that they have been talking to the FDA for a long time now and this is not new to them.

The outlook is bright though IMO since the brachytherapy market is predicted to grow at a good pace in the years to come:
https://www.grandviewresearch.com/industry-analysis/brachytherapy-devices-market

Approval of the IDE will be a huge leap forward. I am hoping for a repeat of the Vermillion story: from 0.02 to $32 in share price in only a few months!!!