ProMIS Neurosciences Inc PMN

Corporate Overview January 16th

[Speyeder999]

PMN310 is still on track for Phase 1a first subject visit 1H2023, so that's encouraging!

https://d1io3yog0oux5.cloudfront.net/_5ed35a6d7a5164ac9639384b0a26866a/promisneurosciences/db/1005/8767/pdf/ProMIS+Corporate+Overview+January+16+2023.pdf

[FarmerBetty]

On track?, why has Promis  been saying since last years Mar 31/21 in May, if allowed to proceed by the FDA ? Then all other quarterly reports for 2021 subject to FDA approval. Maybe nothing just normal protocol! I don't see them advancing wiithout a Pharma partner, ALS and AD programs need expetise in gene therapy and other areas. 

[BottomBroker]

In October, they said they'd have the IND filed by December. We all know that didn't happen. So why believe that they're on track for Phase 1 in 1H2023? Also, there's zero mention of the IND filing in that presentation. Why?

[FarmerBetty]

The exact same overview as before just changed the date! Interesting that the new person Gail is an observer on the board.

[retiredcop]

1) Observer tells me that she is on the board but does not vote on any motions .  2) Reason for delay on filing ... this is my opinion on this ... it appears as  though the world now has 2 approved treatments with the last one being in the limelight just a few weeks ago. All the talk and media coverage is all about getting rid of the plaque.. but the main stickler on this is that there

[M101]

Why would we want to remember Goldstein's "best in class" mantra when we're trying to convince the FDA we're not in that now obsolete class? 

[BottomBroker]

The smaller, more optimistic section of my brain had that same thought, re: your last sentence about the IND having already been submitted. Maybe they didn't include it in this update because it's already been done.  Let's hope so. 

[Speyeder999]

You all brought up valid points. Found this on the FDA site and I'm thinking now they might be further along than I thought (one can dream, no?) They may have already begun their clinical trials if I'm reading this correctly: Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials.  During this time, FDA has an opportunity to

[G1945V]

"Once the IND is submitted,..." To my knowledge, ProMis to date has not announced that they submitted an IND! G1945V

[Speyeder999]

Agreed, and to my knowledge, after doing a 10 minute google search, I don't believe a company is required to disclose a sumission date for a IND application nor will the FDA confirm the existence of an IND appliclation or provide public disclosure of an application. This unfortunately means we're still playing the waiting game for a company announcement or untill they produce their fiscal

[FarmerBetty]

If they did file in December which i believe they didn't,the 30 days should be over or close as it is highly unlikely they filed between Christmas and Newyears.  The AD,ALS and PD programs need to go to a Pharma partner for clinical preparation and trials.  Promis with 5 employees and a few consultants does not have the scientific, technical, regulatory resources etc, to andvance

[Speyeder999]

You are correct Farmer, everything you say is hard to dispute. But this info isn't new and we've known it for quite some time. Whether it will it be a buyout, a partnership or a financing that the new CEO was brought on board for, who knows, it remains a risky play,  one that I'm willing to see how it plays out.  One thing for sure, it's nearing the "$hit or get off