When you say "at the time of ODAC that was all the data MSB represented on the data," given that it is in my opinion a very broad statement, I want to make sure I understand exactly what you mean by that.
- All the data they had analysed at the time?
- All patient data available to them (improved manufacturing process, all trials and - this is where we may disagree - other SR-aGvHD studies where no such data was measured and could have been included, but wasn't)?
The link that I pasted from MSB mentions specifically "Emergency Investigational New Drug (EIND) protocol from 2015-2023" (https://investorsmedia.mesoblast.com/static-files/adfc1ba0-bd4d-47bd-b0a0-a0b3516b0520). I believe they would have had access to the data already, but at the time, the focus was on showing that trial GVHD001 can be considered a well-controlled trial. Once they got the FDA presumably to agree on that point, CRL #2 asked for further data to show that the stockpiled product is the same as the one used in that trial. I think @Bazsa was also saying something to that effect.
As I mentioned before, the 11 data points could be a hindsight 20/20 issue and only really became an issue once they had the FDA in a position to consider accepting that the last P3 trial was acceptable.
You did mention in a post that you'd be happy to considering a bet, as long as you can trust the other party and if your privacy is respected (https://hotcopper.com.au/threads/pick-todays-price-range-low-high-just-for-fun.7975502/page-134?post_id=73665411). Given that a commercial benefit can not arise from posting on here based on the HC T&C fine print, Im happy to offer you the following:
If MSB gets approved (any type of approval even if it includes a P4 trial), I'm happy to transfer you $100 in the form of a gift card of your choice (not enough to be considered commercial in my eyes, but I could be wrong). If there's a CRL #3, provide me with a burner email address to send it to.
If they get approved, I ask you to buy shares in another stock I have been researching at a value of your choice - but at least $100. That way I know you will also have a look at that stock and share your opinion on it (which I would be very interested to hear).
Let me know if you would be willing to agree to these terms or prefer adjustments.
- Forums
- ASX - By Stock
- CYP
- Ann: Investor Presentation
Ann: Investor Presentation, page-598
-
-
- There are more pages in this discussion • 17 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add CYP (ASX) to my watchlist
(20min delay)
|
|||||
Last
19.0¢ |
Change
0.000(0.00%) |
Mkt cap ! $34.32M |
Open | High | Low | Value | Volume |
18.0¢ | 19.0¢ | 18.0¢ | $328 | 1.791K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
5 | 101249 | 18.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
19.0¢ | 118286 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
5 | 101249 | 0.180 |
1 | 285 | 0.175 |
3 | 34148 | 0.170 |
2 | 25050 | 0.165 |
2 | 21200 | 0.160 |
Price($) | Vol. | No. |
---|---|---|
0.190 | 118286 | 1 |
0.195 | 20764 | 1 |
0.200 | 25789 | 2 |
0.210 | 65390 | 2 |
0.250 | 12872 | 1 |
Last trade - 16.10pm 18/09/2024 (20 minute delay) ? |
Featured News
CYP (ASX) Chart |