MESOBLAST LIMITED (ASX:MSB) - Entering the PAZ - give us your predictions!, 75889092, page-180 - HotCopper | ASX Share Prices, Stock Market & Share Trading Forum

Originally posted by reginaldp ↑

Hey Pale One- they want the price before the announcement/trading halt- wouldn't want you to miss out on your prize.
Here is some happy holiday reading for you.
I read this stuff because I have invested money in a speculative biotech- what's your motivation?

Reg

Ps- at least we have efficacy, safety and manufacturing signed off- otherwise I would be long gone

but I'm long, still - not my normal upbeat post- keeping it real
Complete response letters
Vanda Contests FDA Rejection of Gastroparesis Drug, Slams ‘Delayed’ Decision
Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act.
September 19, 2024
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2 min read
·
Tristan Manalac

Approvals
FDA Denies Approval of Regeneron’s Linvoseltamab for Multiple Myeloma, Cites Third-Party Issues
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
August 21, 2024
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2 min read
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Tristan Manalac

Complete response letters
Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
July 17, 2024
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2 min read
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Tristan Manalac

Complete Response Letters
FDA Rejects Novo’s Once-Weekly Insulin Injection, Cites Manufacturing Process
The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.
July 11, 2024
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2 min read
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Tristan Manalac

Policy
FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info
Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.
June 28, 2024
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2 min read
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Tyler Patchen

Policy
Merck’s ADC Pact With Daiichi Hits Regulatory Setback in FDA Rejection
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
June 27, 2024
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2 min read
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Tristan Manalac

Policy
FDA Again Hits AbbVie Parkinson’s Treatment With Complete Response Letter
Citing issues with a third-party manufacturer, the FDA has issued another Complete Response Letter to AbbVie rejecting its New Drug Application for ABBV-951, a proposed treatment for motor fluctuations in adults with advanced Parkinson’s disease.
June 25, 2024
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2 min read
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Kate Goodwin

Policy
FDA Rejects Dynavax’s Bid to Expand Use of Hepatitis B Vaccine
Dynavax Technologies announced Tuesday that the FDA issued a Complete Response Letter to the company’s sBLA to include a four-dose regimen of Heplisav-B vaccine for adult hemodialysis patients.
May 14, 2024
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2 min read
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Kate Goodwin

Policy
FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
April 23, 2024
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2 min read
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Tristan Manalac

Policy
FDA Again Rejects Supernus Drug-Device Combo for Parkinson’s Disease
For the second time in as many years, the FDA has hit Supernus Pharmaceuticals with a Complete Response Letter, citing undisclosed quality and master filing issues for the drug-device combination.
April 8, 2024
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2 min read
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Tyler Patchen

Drug Development
FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
March 25, 2024
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2 min read
·
Tyler Patchen

Policy
Acadia Axes Antipsychotic Candidate After Phase III Schizophrenia Failure
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.
March 12, 2024
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2 min read
·
Tristan Manalac

Policy
FDA Rejects Viatris, Mapi’s Long-Acting Multiple Sclerosis Injection
With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
March 11, 2024
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2 min read
·
Tristan Manala

Expand

So what's your point?

(20min delay)
Last $1.13		Change 0.035(3.21%)		Mkt cap ! $1.284B

Open	High	Low	Value	Volume
$1.09	$1.13	$1.07	$3.910M	3.535M

No.	Vol.	Price($)
4	31763	1.100
2	33264	1.090
2	18897	1.085
2	18926	1.080
1	18000	1.075

Price($)	Vol.	No.
1.130	23400	3
1.135	1090	1
1.140	65000	4
1.145	64500	3
1.150	92314	9

So what's your point?

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Top Stories

Estrella first foreign entity to win tenements in Timor-Leste under new laws ahead of 2025 tenders

Week 39 Wrap: What HotCopper’s watching; China’s new stimmy moves boost metals; Oz CPI drop

HotCopper users muse on De Grey's denial of Agnico Eagle takeover bid – but who are Agnico?

The winners & losers on market if negative gearing were gone

KalGold rolls out detailed aeromagnetic survey across Pinjin project

ACCC seeks Olam divestments before it can buy Namoi Cotton

The market's shrugged at China's stimulus measures all year. Why is this one different?

5.6g/t gold intercept at Serbia's Rogozna supports Strickland's hopes for high-grade core

Actinogen Medical ramps up Alzheimer’s treatment trials, targeting fast-track global approvals

Coda Minerals (ASX:COD) enters rights issue to further exploration in South Australia

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Buyers (Bids)

Sellers (Offers)

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