CYP (ASX) What questions do holders want asked at the AGM?

Originally posted by JB1975: ↑

You wrote in bold (my numbers for reference) -

"Yeah the IND clearance from the FDA is a critical validation step."...........for Cynata's ongoing commercial partnering activities. (1) No ongoing partnering activities, no trial BECAUSE.....you guessed it, you need money to do FDA trials AND lots of it. (2)

The information presented assumes you can work out for yourself that the trial isn't free. (3) Cynata is also not explaining that whilst you read their announcements, you must continue to inhale and exhale or you will expire.

I think you are just not wanting to see it. Coupled with they not wanting you to see it.1) IND clearance for phase 2 GvHD is a necessary but not sufficient step for seeing if they can identify clinics in my opinion (but I retain some concerns they may not identify clinics and patients first because if the MEND trial fiasco). And its also a critical validation step for getting partners in GVHD if they can and choose to. But unlike you I don't think they absolutely have to get partners - its possible they could go it alone - but I'd rather CYP not do that with this management.

What I do agree with which a CYP announcement suggests is that the US is a gateway and that getting FDA IND approval a) shows they can - they aren't incompetent to do that and b) allows recruiting to be explored in the US - without it they effectively couldn't the clinics wouldn't think they were ready or credible, and c) it would help in other indications besides GvHD and so in other ongoing commercial partnering activities (if there are any) in the United States if CYP management could show some success in the United States - an IND FDA clearance for p2 GvHD is some success, but a successful clinical trial (whoever funded it) would be some more - that would help CYP in the US and generally if it showed competence. But I still maintain that CYP shouldn't automatically do a trial in p2 without doing a feasibility into recruitment regardless. Because a trial will cost some money (whoever pays) and it might not be money well spent. And DFU and OA are also potential ongoing commerical activities - better chance to have money for those if its not wasted on a p2 GvHD that isn't planned properly (which I feel could happen). But they may plan it properly - that's possible.

2) When I asked you for an estimate on the amount of money you just waved in the general direction of MSB but didn't offer even a rough figure. I don't accept that you know enough or have thought this through enough if your don't intemise the costs expenses with respect to CYP and p2 GvHD in the US.

I also don't accept that checking out MSB is the most sensible way for CYP to cost itemise a p2 for GvHD in the US. That doesn't mean I won't read what you write on that subject if you do the work to collect some relevant MSB costs that would apply to CYP costs.

3) Absolutely nobody has ever suggested doing a trial is free. That's a pure straw man by you. Everybody knows it will cost something - but I don't believe you know or anyone knows exactly what it will cost until the prospects of getting the 60 are more fully explored. Because its getting the 60 or not that determines success or not.

Let's go back a bit.....

"Cynata and Fujifilm intend that Fujifilm will have first rights (4) to manufacture clinical and commercial requirements for Cymerus therapeutic MSC products. In addition, and in recognition of the progress made by Fujifilm, Cynata will pay Fujifilm a proportion of any upfront licence fee received by Cynata if Cynata approves main terms of a GvHD licence agreement with certain third parties within the next 6 months. "I remember that quote. 4) Gives me some concern still because it implies that Fujifilm might decline to manufacture in some circumstances (first rights do not equate to an obligation or commitment to).

It looks to me that the hole of 'progress' with GVHD just keeps getting dug deeper and deeper.

No money, no trial. It's that simple.

CYP has money and has a capacity to raise more - no one is suggesting we don't - you aren't saying how much money and I'm saying within reasonable ranges say $5m to $50 million CYP might be able to get it (but absolutely shouldn't spend it on p2 GvHD without better planning first to see if the trial should go ahead at all because it could be a waste of money if they do).

As I've said before, think about the 'sales pitch' to prospective partners that are CRITICAL to this trial progressing. Wow - just wow.

I do not regard even Ross's continuation in the company as critical. In fact I'm almost of the opposite view, its almost critical he doesn't remain in charge unless to massively lifts his game - which is the purpose of a thread on KPIs and questions - to prompt a drongo that won't leave to lift his game.

Candidates enrolled by the end of the year? Planning for the trial has commenced? Get them to add 'color' to these two little gems.

Whilst it is possible that candidates may be being enrolled by the end of the year I do not even hope for that - I only want that if the trial is well planned. It could be and likely will be wiser to not recruit a first patient by year end if it is not clear from the FDA and MSB what has happened with a BLA resubmission in the United States. What happens between the FDA and MSB on GvHD in the US will illuminate the game field somewhat both as to what the FDA will accept or not (on assays and data) and as to a competitor will be doing in the US on recruiting patients into similar trials (like phase 4 adults).

Your suggestions that shareholders should seek color on the whether candidates will be enrolled by the end of the year and whether planning for the trial has commenced are noted.

But you aren't a shareholder.

Expand

“I also don't accept that checking out MSB is the most sensible way for CYP to cost itemise a p2 for GvHD in the US.”

Wow. Apples vs oranges, hey?

Convo over. You win because you’re a shareholder. Like hector. And Ross.

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