Hello Everyone,I just thought I would provide my two cents...

Hello Everyone,

I just thought I would provide my two cents regarding the news release from Paradigm and the FDA.
I thought the update was 90% positive and 10% negative.

The FDA typically want to be thorough for this process. I believe that since Friday 26th March, Paradigm have sufficiently and adequately answered the "few" questions provided by the FDA. The bulk of questions have probably already been answered regarding the actual clinical data.

Due to the massive submission of a 30,000 page application, it is common that the FDA would still have some pending questions. I think it is very positive that most of the questions from their brief discussion with the FDA will be about the submission of non-clinical data, rather than actual clinical / scientific data. I believe this application process will ultimately be completed soon. The FDA can be rigid with their guidelines, but in my experience, this is typical, but definitely should not be interpreted as a huge negative.

My 10% negativity in the announcement is more due to the time delay, but I would always be looking to top up a position in times where the market becomes impatient. Nothing material has impacted the long-term story of the company. The times where I would be looking to top up are when there is a bad earnings release, a regulatory issue or simply just market neglect.

This inefficiency could last for a day, or a week, or occasionally longer, but will be short-lived once Paradigm easily answer pending questions. Your job as an investor is to take advantage when these dislocations occur.

Stay safe everyone, I am confident that we will be opening the indication soon.