Australia's largest stock trading and investment forum Australia's #1 stock forum

CYP

Click for more information

0.00%

25.5¢ cynata therapeutics limited

Ann: Investor Presentation, page-521

First 521 Last

Share
Profile

Follow
truss20

834 Posts.

339

18/06/24

16:17

Post #: 74373525
Share

Originally posted by JB1975: ↑

I'm not sure whether you've discussed it more on other threads or not, but I figured it would be interesting to hear more your thoughts about this as I think we might be on the same page here.I did some. But frankly I'm finding HotCopper difficult to read and post into at present - the poor behavior which I see as motivated by greed (traders many of whom are mostly ignorant pumping nonsense often to the other holders) I'm finding depressing as its so wide spread.

Essentially, MSB were unable to get approval of Rem-L in paediatric Gvhd. This was/is due to the current clinical trial data being not being adequately controlled and related potency assays were not sufficiently related to the mechanism of action.Yes

However, as I read it in the paper, SI walked into the latest meeting with the FDA and was told "actually, we’ve thought this through, and you’ve convinced us that the clinical data are very strong."Yes. Cameron England is the reporter. I wondered if he might be a rookie or someone interviewing out of his field and so might have quoted Silviu incorrectly - that rookie and out of his field doesn't seem so likely from what I saw searching on his name. He says he's interested an reported on integrity in business or some such.

Nonetheless it still seems to me that some of what he quotes Silviu as saying the FDA said still almost beggars belief - to the point where the FDA according to Cameron quoting Silviu is almost giving business advice in pithy little quotes like (haven't got it in front of me so I'll paraphrase ('pediatrics looks good go ahead and then do the adults later').

This is...weird. Why would the FDA assess this twice, come back with the same outcome both times (you need to do another well-controlled trial), but now backflip and essentially admit their previous two assessments were wrong? Indeed.

My best guess (and I have put no effort into researching this), is that there is a new person assessing regenerative therapies at the FDA.I understand some of the personnel have gone - Steve Bauer for instance and some others that were at ODAC - but not I believe Matt Klinker who was the principal investigator and I though had become the head of the dept that Steve Bauer used to head. Its inconceivable to me that he could reverse himself so much without new data (to be absolutely clear - I think he was absolutely right in his science and stats assessment and I know from reading his papers with Bauer that he really did understand MSC potency at an expert level).

A new person (in my opinion they'd have to be a less capable person or persons or someone caving to political pressure from inside) because the science is clear. (I'm open to being wrong on the science too btw but I honestly don't think I am and there seems to be no-one around on the HC forums that can go with me on it to point out what I'm missing (and every time I try to engage on the science the idiot traders attack my character and motives to shut me up so they can resume pumping their bs- pfeifer seems to be the most thorough researcher and seems to understand the science stuff afterwards even to the point where he can condense what I say but I say this trying to be respectful I think he possibly hasn't got quite the same level of understanding of some cell biology technologies that would be behind things like cell sorting maybe. I'm open to being wrong on the science too - but the engagement isn't there on that. And I got the call right ahead of the CRL # 2).

TLDR - New personnel are a possible explanation. But I still think human error - Silviu misinterpreting or hearing what he wants to hear and then dumbing down so he gets quoted in more pithy sand bites for better copy (with respect to the paper) seems more likely.

Would you be interested in emailing Cameron England the reporter with me and saying saw you article and was surprised and impressed by the quotes relating to Silviu as they sound a little different to how we expect the FDA to speak would he mind confirming that that was exactly what Silviu actually said and that he didn't accidentally abbreviate him or something?

I am certainly not suggesting Cameron England would have done anything other than make an innocent mistake - but he might confirm and say - actually I'm sure I recorded Silviu and that's exactly what he said.

They are of the opinion that a trial can be "adequately controlled" with no control arm in conditions where survival outcomes on standard of care are low. This flies in the face of the FDA approval process, but short of suggesting something criminal has occurred, or that SI was just talking out his backside in the article (which I guess would also be criminal), this is the only way I can see MSB as having gotten a green light to proceed without another clinical trial.

What are your thoughts? Well my thoughts are above. If the FDA does have new personnel and they do approve this - it would be a serious error in my opinion - like a judge getting something wrong.

They would have to validate the potency assay implicitly to give a BLA -and honestly I don't think on the science they should do that - but if they did, the US patent office would likely not second guess the FDA over a potency assay and the USPTO might patent a broad patent that doesn't actually work but could block others from using some natural occurring pathways.

Expand

Silviu misinterpreting or hearing what he wants to hear and then dumbing down so he gets quoted in more pithy sand bites for better copy (with respect to the paper) seems more likely.

This is definitely a possibility.

Would you be interested in emailing Cameron England the reporter with me and saying saw you article and was surprised and impressed by the quotes relating to Silviu as they sound a little different to how we expect the FDA to speak would he mind confirming that that was exactly what Silviu actually said and that he didn't accidentally abbreviate him or something?

Yes - I no longer have access to the email I previously contacted you with. Can you please advise the best email address to contact you on (if you think that is necessary before contacting Cameron)?

Last edited by truss20: 18/06/24

CYP Price at posting: 30.5¢ Sentiment: Buy Disclosure: Held
4 Upvote

0 Great analysis

Reply

Top Stories

BIO

Biome unveils three year revenue target up to $85M – but are 3Y targets enough to excite?

IVZ

Invictus banks US$5M from Zimbabwean investment fund in support of Cabora Bassa

AZL

Brine and shine: Arizona Lithium wins early stage eco approval to commence wellpad #2 at Prairie

BOE

$550 million Jabiluka uranium offer comes unstuck as Government rules lease won't be renewed

PAM

PAM secures high-grade Chilean copper play in strong territory

There are more pages in this discussion • 89 more messages in this thread...

First 521 Last

Add CYP (ASX) to my watchlist

(20min delay)
Last 25.5¢		Change 0.000(0.00%)		Mkt cap ! $45.80M

Open	High	Low	Value	Volume
25.5¢	25.5¢	25.5¢	$3.545K	13.9K

Buyers (Bids)

No.	Vol.	Price($)
1	20209	25.0¢

Sellers (Offers)

Price($)	Vol.	No.
26.0¢	36715	1

View Market Depth

No.	Vol.	Price($)
1	20209	0.250
2	49573	0.245
2	102000	0.240
1	100000	0.235
2	15173	0.230

Price($)	Vol.	No.
0.260	36715	1
0.265	8119	2
0.270	30000	1
0.290	1900	1
0.295	183892	1

Last trade - 10.06am 29/07/2024 (20 minute delay)

CYP (ASX) Chart