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Medical director uses new technology to save horse’s skin after massive barn fire
https://www.12onyourside.com/2024/08/02/medical-director-uses-new-technology-save-horses-skin-after-massive-barn-fire/
Up 12.14% today and another 26.0274% in after hours training. Something's happening. Maybe someone leaked positive info about the Phase 3b trial.
Great day today! Up 31.03%. Hope to see a lot more of this.
What is going on with this stock? It is getting hammered.
The Aussie stock closed up 12.59% tonight.
Any idea how long we will have to wait before we get the results from this phase 1? Also, if the results end up being very positive, what are the chances that the FDA will let them advance directly to a phase 3 trial?
Hopefully, they will set higher ALSFRS-R scores in the new study for the trial subjects so there will not be a floor effect again. Also, in a perfect world where everything goes our way, how long do you think this new study will take before we see the results?
Here's a detailed presentation about Recell.
(warning: some of the pics are very graphic)
https://avitamedical.showpad.com/share/NAPlEVouN92Enz79yKX4z
It's weird that the news only caused a 2% pop to the stock.
Did that bump happen today?
That drop seems pretty excessive.
Kinda amazed that the stock price only plummeted to 19¢. I was expecting around 5¢ to zero range.
I want to be positive but I'm having trouble seeing a possible path out of this mess. Michelle Lorenz from the No More Excuses ALS Facebook page is already planning to flood the offices of every senator and representative with phone calls to somehow convince them to get the FDA to vote for Nurown in the official PDUFA vote in December. But even if by some miracle that happens, where is Brainstorm going to get the money to stay afloat and fund a new 100+ million dollar trial?
I doubt that they can dilute their shares more since the stock price is down to 19¢ and I don't think that a bank in today's economic environment will give them a 9-digit loan. What plausible options does Brainstorm have?
Conclusions:
Preliminary results from this pilot study of MCGN in mPDAC were promising, with a durable PR rate of 55% and disease control rate (DCR) of 82%, compared to historic PRs and DCRs of 23% and 48% reported with gemcitabine and nab-paclitaxel (GN), respectively. Based on these results, the study was amended to transition to a randomized phase 2 trial testing MCGN compared to GN (N=112). The primary endpoint is progression free survival (PFS).
"The Committee's vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease," said Stacy Lindborg, PhD, co-CEO of BrainStorm. "We firmly believe that the totality of data presented for NurOwn today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response. We truly did our best to make the NurOwn data clear to the FDA Advisory Committee. Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed."
Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added: "The discussion in today's Advisory Committee meeting, and the heartrending testimony of those living with ALS and their loved ones, underscores not only the need for regulatory flexibility but also for continuing research in the field. The people of BrainStorm will do everything in our power to fulfill the obligation we deeply feel we owe to the ALS community, and in the coming weeks we will explore all options available to us."
1 YES - 17 NO - 1 ABSTAIN
So, I assume this is officially the end but should we still wait for the PDUFA for some sort of miracle?
What do you think Brainstorm's odds are of getting positive news from the FDA tomorrow?
Just bought another 3,300 shares.
Wish I heard about this board in February.
I found out about this stock when it was at $1.66.
Hot damn! That is some friggin' great news to wake up to!!! Congrats eveyone!
So, do you think that the FDA's decision will get posted before the morning bell on Monday or do you think that we will have to wait for the closing bell before we hear the news?
Does anyone find it bizarre that there are no financial news stories posted about BLRX today?
Don't forget that BCLI's AdCOM meeting with the Fed is coming up on September 29th. It would be awesome to get positive news from the Fed for BLRX and BCLI. Hopefully, with positive news, my Brainstorm stock will do a 180 and shoot back up to where it was just prior to when the Fed originally rejected their phase 3.
I forgot to mention that the StockTwits post was published in Nature:
I prefer to be extremely overoptimistic with a stockprice of $450.
Uggh...the waiting is just excruciating.
It would suck if the FDA makes us wait 'til Monday.
Hopefully we will get positive news from the FDA tomorrow morning. If that does happen, where do you think the stockprice will end up at by the closing bell?
Kinda nuts that the stock was just $1.28 last Monday. My stake is currently 48% in green territory.
The stockprice briefly broke past the $2.50 barrier. I'd love to see it explode past that and end up near $3 by the closing bell.
I'd be ecstatic if it reached $5 by Friday but 19 bucks is probably outside the realm of reality.
Where do you think the stockprice will get pushed up to prior to the FDA decision? I've been hearing between $2.10-$4 range. The higher the better imho since positive news will translate at a minimum to an 80-100% jump to the stock price.
If everything rolls our way with an FDA approval, how much do think the stock price will jump on it's first full day of trading?
Also, September 9th falls on a Saturday. Do you think we will get the FDA decision on Friday after the closing bell or on Monday morning before the starting bell?
Here's the pdf file listing those who we KNOW got NurOwn in EAP or Phase 2, with hyperlinks to their Public Statements filed with the FDA as of August 17, 2023.
https://www.facebook.com/groups/NOMOREEXCUSESALS/permalink/1038725100403214/