MST - Presentation 17th June 2021, page-2

PART 2 - MOZZ NOTES


You guys have kinda mentioned all the questions but this is what I noted.
I wouldn't have started a new thread if I remembered (and saw) that Eire had one going, apologies.



QUESTIONS

Q1. Number of trials running concurrently - what will all these trials bring to the table ?

Once P3 is finished there are many things to be done before NDA gets approved. FDA wants extra data eg label , how often to redose, whats durability? Effect? Does it work in other joints? These are key q's to be answered. When P3 finished then we will have that data to move into submission in terms of NDA.

While we are working p3, we are not just focused on the read but but on registration and labeling too. We need this labeling data to negotiate ad funding with payers and insurers. They will want this data. One of our Doctors mentioned that he thinks there a lot of the patients that are able to get good pain relief and good Global Impression of change. They can do activities for up to 2 years in terms of durability of the drug.

This will be important data when going to insurers. This can result to higher price generation due to the longer durability aspect/effect. "Fast on, slow off" effect. The durability of effect is to be studied. We will wrap this up for NDA. We will have all the info ready to go for regulator and insurers to negotiate. Eg Pain and Hip OA possibly in Europe (Mozz note: which broadens the label).

Retreatment safety and efficacy analysis. All happening at same time of P3..so we can package it together to quickly apply for registration. "The money starts to roll in after NDA and after the negotiations with the insurers" more value gets built into the opportunity.

(I liked this statement, it's like they are utilising efficiency and doing multiple things at once rather than just in tandem....parallel is better, preparation and forward planning....what do we need for registration and negotiations? Let's work on this NOW though it is months away).


Q 2. COMPLEXITY of FDA questions/inquiries?

"The complexity is relatively low level".

The FDA provided PAR with a formula to answer the questions in terms of the observations they made as a result of the new preclinical observations. Are these observations clinically relevant? If so, what mitigation programs have we got in the protocol.

The complexity wasn't enormous. We notice this is a certain number of rats in tox studies. The FDA were interested to know if PAR thought it was clinically relevant.


Paul then mentioned an important point of observing such data in rats compared to larger animals such as dogs. Ie Tox data for example (Mozz view).




Q 3. It's been almost 30 days - what does that mean in terms of complexity?

We are attempting to make sure we have a response that puts these questions to bed once and for all. (Questions are comprehensively answered). Ex FDA employees that we are consulting with are advising us in terms of quashing questions.

Time consuming but we are doing all of the necessary work to answer comprehensively,





I thought it was a good presentation!

What did you guys think?