MSB (ASX) Ann: CEO Presentation to 2021 Annual General Meeting

Originally posted by Bazsa: ↑

Overall a very good AGM . Some may be disappointed in the lack of clear time frames. This is equally true for the shorters. They simply don't know what to expect so at the moment it is a investment for the future growth or decline depends on were you stand . @18% cost to shorters they will remain buyers on low volume.

In relation to the Covid ARDS .
The FDA will have to agree with our potency assays or they will not be able to use our cell therapy or any other cell therapy for Covd ARDS without having a very difficult position to justify. OTAT meeting yet to happen however I cannot see it likely that they would not lift the hold on starting the ARDS trial under the current situation, delaying the start of a confirmatory trial would result in a lot of bad press.

Trial design.
Seems that SI is wanting to replicate the findings of our first trial by simply making sure only those that responded in our last would be enrolled this time around. He also mentioned the need for a quick end point, in this trial it would be 60 days.

Could I suggest that a cross over trial would full fill SI requirements above and give a much faster endpoint of say the running % that cross over from control to treated at day 7 .Those that cross over would be those that would be enrolled however we would have already collected very valuable data up to the 7 day mark. Is it not better to stop people going onto ventilation rather than waiting for them to be ventilated and having a cocktail of other drugs that may or may not help, complicating the end results.

So a trial starting after Dex. was found lacking with inflammation markers present and uncontrolled by Dex.
Probably 24 hours after first Dex. treatment and continuing up to 4 treatments based on inflammation markers and patients wellbeing . This allows the older population to be treated that may not be willing to be ventilated. Those progressing to ventilation would be followed for the 60 day survival endpoint and be considered confirmation of our last results.

The advantages ,
Up to 75 % of patients would be eligible to go into the treatment groups yet maintaining a equal split on treatment and control group . This would reduce trial costs and improve speed of enrollment.

Early ongoing 7 day results would give very clear guidance to the suitability of the therapy. May even be sufficient for a fast EU application while the trial progresses.

On to management. Much over the last 12 months has been said about the quality of management due to the failure of primary end points in our trials and announcements not containing the information that particular holders or none holders want. By the results investors have overwhelmingly supported the board.

Congratulations to Management . We could have been in a significantly worse position, now we have 2022 to look forward to.

Good luck all.

Expand

re trial design..today i asked about the requirement for mechanical ventilation to enrol. my understanding from his response is that this requirement will remain. and that will allow the new data to supplement the existing and give the best chance for the eua in the most severe cases where there remains an unmet need. so i dont think we are going to see too many changes or any fancy crossovers. and this is of course assuming the green light from otat.

however he did acknowledge the potential to treat patients earlier in disease process and hghlighted the point that it would require much less use of cells (lower dosage)

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139719

1.150

139603

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154701

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193990

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1.155	45740	12
1.160	116716	15
1.165	109468	11
1.170	69529	11
1.175	38655	5

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1.155

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38655

(20min delay)
Last $1.16		Change 0.005(0.43%)		Mkt cap ! $1.295B

Open	High	Low	Value	Volume
$1.15	$1.16	$1.11	$4.759M	4.191M

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