Cytodyn Inc (CYDY)

[Irishvox]

I recently had a meeting with the FDA about submission of a product that we are working on. The meetings last exactly 1 hour to the minute. On their end they had 9 PhD scientists on my end my FDA consultants my quality & regulatory managers myself and a couple of engineers.

I can’t even begin to describe the amount of effort they went through in deliberately evading any guidance or any concrete answer as to the path forward other than to expect the process to be de novo 510 K. If one scientist would start to answer a question directly with useful data another would interject themselves and quickly redirect the answer into more nebulous ambiguous response.

I understand the process especially the notion that you need to put forth your intended use for a product and provide the data relative to validating the claims you seek my problem is that the FDA goes beyond neutrality and are agnostic relative to the companies size status or potential clinical benefit or impact of the product they seek to get approved.

What was most interesting was after you submit your meeting minutes to the FDA within a week of the call you get a schedule survey meeting where you discuss your take on the effectiveness of the meeting. The surveyor was most concerned and the majority of the questions revolved around a perceived fear that you would take your product to a foreign country to seek regulatory approval because the process would be more straightforward less time-consuming and less expensive.

When companies complain about the regulatory restrictions in this business this is exactly what they are talking about. I have been doing this for close to 30 years and I’ve never had less competition in my life and the reason is is because you’re better off making the worlds next gym shoe then you are getting into the medical industry. The industry has become overwrought with regulators that stifle innovation. I have seen game changing products that never made it to the market because the companies couldn’t ride out the wave of regulatory requirements and died on the vine financially trying to get there.