MSB (ASX) Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L

Originally posted by The Yankee: ↑

I am compelled to address two things today in this post.
First - the share price decline (more a dive) the past 2 days
Second - public comments on the ODAC/ADCOM FDA website which I reference to my previous post above (quoted above).

Share Price:
Someone from HC asked for my opinion on the FDA Briefing note and the share price dive. As you probably know by now, I usually do not comment on Mesoblast share price and refrain from share price projections/predictions. But since this someone asked me (by email), I am compelled to provide my 2 cents:
Here is my take (this was my email reply to the HC member):
"Been busy all morning in meetings but wanted to get back to you during lunch hour. Remember the 35 million or so shorts on the ASX? Well, they had to cover. And cover they did! Look at the ASX volume - 51 million on Tuesday. Are you telling me this is not short covering? Retail cannot be remotely close to that volume. @ddwn keeps saying short squeeze but believe me, short squeezes are very rare. Shorts are pros. Majority are hedging against price fluctuations. They rarely get squeezed. Retail investors who panic and sell are the ones who get squeezed.
Here is the thing: Shorts knew the prior issues from the Osiris days and also knew that this is the first allogenic stem cell treatment that has come up for approval. So the FDA was bound to have questions.

Also note how there was no Press Release anywhere? Neither Mesoblast or FDA "officially" released anything before the sp tanked.

Here is the sequence:
1. The sp ran up on no news the past few days - this was the work of pro shorts.
2. Then the FDA briefing got "released" but there was no PR. Some "random" posters on HC posted it. (It's not by accident that they posted it). At the same time, MESO tanked in after hours trade. Repeat, After Hours. This was done to trap longs from selling - most people (retail) don't trade after hours. Pros tank it by selling small amounts of shares in after hours. The after hours volume was just over 100,000 ADRS, not a lot.
3. Then they used the tanked MESO price as the basis to open MSB on the ASX lower, again, trapping the longs on the ASX
4. Our dual listing on the ASX and Nasdaq really makes it so easy for the pro shorts
5. I have noted so many new posters (negative ones) on HC since the last 2 days - coincidence? Nah. So this was a short attack. Well planned and executed to perfection.
The only way for retail longs to win and win big is to ride it out.
Look, Temcell has been selling for 4+ yrs in Japan (safety + efficiency) and there was no issue with mfg or batch consistency. I am not worried one bit. Just pissed that pro shorts win every time."

Secondly, I want to address the public comments on the FDA website:
Recall that I had urged you to submit comments?
Most of you were in favor but some were against it.
@Anjo-Roch in your Post #:46406511, you had checked with your friend the Specialist who discouraged comments from "shareholders".
I respectfully disagree. Firstly, commenters do NOT have to declare themselves as shareholders when they comment at the FDA website here:
https://beta.regulations.gov/document/FDA-2020-N-1539-0022/comment
In fact, they can comment by choosing option "Individual Consumer".
Secondly, even if say, I was not a Mesoblast shareholder, I would still be interested in having this Ryocil aGVHD therapy available to me or my kids. I may care zero about Mesoblast share value but I would care a whole lot about this life-saving therapy that I would want available for everyone, more so myself (adult aGVHD) or my kids.
What would your "Specialist" say to that?
@JonesingPanda - I think you commented that people would be "deluded" to comment on FDA website (reference your Post #:46401389). I am sorry but I am not delusional. Nor are the people who already commented.
One doesn’t need to have a relevant university degree in science, experience in this field, or have personal anecdotal experience with the diseases in order to be concerned about FDA disapproval. As I said above, I am concerned because I need this therapy in the unfortunate event that I get aGVHD or my kids do. I am tired of drugs that do damage. Hence I comment. Not because I am a shareholder. The therapy would be used by "common" people, not just those with a university science degree.

There were 5 public comments at that website on August 8th, 3 negative and 2 in favor.
Today, as I write this, there are 18 comments.
14 positive - in support of approval (2 from Australia, one from Germany, one from New Zealand and the rest from the US)
4 negative - 2 from Lassman Law and 2 from Anonymous.

By the way, thanks to HC members who submitted their comments.

By the way, here is a well researched article that says "Findings show that the odds of a committee voting in favor of approval are 11.3 times higher when committee members are exposed to a positive OPH (Open Public Hearing) than a negative OPH"

https://3dcommunications.us/do-public-hearing-participants-influence-outcomes-of-fda-advisory-committee-meetings/

Interested members should read comments at the FDA website:
https://beta.regulations.gov/document/FDA-2020-N-1539-0022/comment?sortBy=postedDate&sortDirection=desc

Obviously, I leave it to your discretion to submit comments or not.
I am NOT saying positive comments will win the FDA approval. Trial results will. But positive comments will help. Not hurt.Mesoblast = Togo

Expand

Thank you for the great post.
I was just about to comment, but have missed the deadline damn it.

No.	Vol.	Price($)
1	15000	$1.32

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15000

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$1.33	7070	1

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7070

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1	15000	1.320
4	52476	1.315
2	38920	1.310
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15000

1.320

52476

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38920

1.310

36000

1.305

41291

1.300

Price($)	Vol.	No.
1.330	7070	1
1.335	20000	1
1.340	19777	4
1.345	90791	6
1.350	36184	3

Price($)

Vol.

No.

1.330

7070

1.335

20000

1.340

19777

1.345

90791

1.350

36184

(20min delay)
Last $1.33		Change 0.045(3.50%)		Mkt cap ! $1.518B

Open	High	Low	Value	Volume
$1.30	$1.35	$1.30	$2.885M	2.183M

Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-588

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