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European Marketing Authorization for LYTENAVA™ granted!
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-receives-european-commission-marketing
Best of luck with your investments!
Positive or negative, the EU is supposed to give its verdict this week for ONS-5010.
Let's see if they keep to their timetable. I'm cautiously optimistic.
Best of luck with your investments!
By my calculation May 28th would be EU decision date. That date, I think, would be 67 days past CHMP decision.
European news within a couple of weeks?
That's what the May 14th PR hinted at:
yes, very likely
Now I’m curious if Thermo is optimistic about EU approval and OTLK going forward haha (I would assume so if you’re still buying) :)
I think approval is likely, as you said, based on the current unmet medical need. The combo results, although probably not taken into account for MAA appoval, are also very encouraging.
Would be very disheartening if the application is rejected, knowing DCVAX can help so many people.
Anyway, have a great day. I'll stop bothering you lovely OTLK folks with my NWBO nonsense :)
Cheers!
Everyone knows all that really matters is an MHRA approval. Most of the talk on that “other” board is just rehashing the same set of opinions, many of them disingenuous, but others are just restatements of prior positions with no new information behind them.
I know some things other people don’t know – like conversations I've had at medical conferences with some of the clinical trial investigators (and they strongly believe in the therapy), and several other topics – but none of it is conclusive and I don’t know if MHRA will grant approval. Approvals always carry risk. They’re mostly about the data and trial design but they’re also about unmet medical needs and incentives within agencies. The company has a shot and if the therapy is approved everything changes… credibility, financing options, combo-trials etc.
Still curious about your thoughts moving forward? (Sorry to you OTLKs for crossing board).
I find the NWBO just too littered with junk. It wastes my time.
The same, but for NWBO :)
....
Or do you have ... NaDA to say?
How do I feel about OTLK? Stock acts crappy but I'm bought the last few days.
This stock isn't behaving like the company is a few weeks away from EMA approval. Did the FDA's CRL leave investors feeling once bitten, twice shy?
May 13 PR: MHRA Submission / Under IRP
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-uk-submission-marketing
2 more sites, so now 58
* Laguna Hills, California, United States, 92653
* Hagerstown, Maryland, United States, 21740
They may go for the 60 planned or not, depending of the recruitment progress. The primary completion and study completion anticipated dates remain the same.
And end of May (European decision) is tip-toeing forward.
Best of luck with your investments!
May! Here is to good news before the end of the month.
The March 22nd PR stated that:
1 more site -> 56 as of April 24th
-> Lenexa, Kansas, United States, 66215
I also pay attention to the completion dates. They have not moved since the first version on clinical trials. They are:
* Primary Completion: September 2024 [Anticipated]
* Study Completion: October 2024 [Anticipated]
with the resubmittal planned by the end of the year. Even if it moved a bit, say January, that's in the ballpark.
At this stage, OTLK must be seeing the current enrollment and continue to plan accordingly. The completion dates can be updated with each new revision. And they keep being the same.
I'm not sure that all 60 planned sites are necessary for the enrollment. It's now 56 recruiting sites out of 60 planned.
And then, there is the end of May European decision.
Best of luck with your investments!
Hey Thermo! It’s been awhile since I posted and I like to always check in with you and ask how you’re feeling about the current situation. Within the board/company does the outlook seem positive? Any information you can share with the average investor that might help us understand everything happening.
2 more sites -> 55 as of April 16th
Arcadia, California, United States, 91006
Pasadena, California, United States, 91107
Close to the 60 planned sites. Around end of April for the remaining sites sounds doable. If they need them.
Best of luck with your investments!
H2R Thank you. I agree.
Thanks someconcerns
That follows what they announced on March 18:
Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million
GlobeNewswire - 21 minutes ago Investment News
Email Facebook. Twitter. LinkedIn. Print
ISELIN, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement with Syntone Ventures, LLC, an existing stockholder, for upfront gross proceeds of approximately $5.0 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting offering expenses. In addition, Outlook Therapeutics ( OTLK ) has the potential to receive additional gross proceeds of up to $8 million upon the full cash exercise of the warrants issued in the private placement, before deducting offering expenses.
About the Private Placement
Pursuant to the securities purchase agreement entered into on January 24, 2024, Outlook Therapeutics ( OTLK ) issued to Syntone an aggregate of 714,286 shares of common stock and accompanying warrants to purchase an aggregate of 1,071,429 shares of common stock, at a price of $7.00 per share and accompanying warrant to purchase one and one-half shares of common stock. The warrants have an exercise price of $7.70 per share and are exercisable only for cash until their expiration on the fifth anniversary of the issuance date. The warrants include a feature that allows Outlook Therapeutics to require Syntone to cash exercise the warrants if certain stock price and milestone conditions are met.
All of the securities in the private placement were offered by the Company.
$46.43 Consensus PT from Analysts
https://www.marketbeat.com/instant-alerts/nasdaq-otlk-consensus-analyst-rating-2024-04-13/
A bit similar to the article from 3 weeks ago
https://www.marketbeat.com/instant-alerts/nasdaq-otlk-consensus-analyst-rating-2024-04-13/
Probably generated from data from back then, but still interesting.
Best of luck with your investments.
53 sites as of April 10th
Added sites:
Long Beach, California, United States, 90807
Lexington, Kentucky, United States, 40509
7 to go if they want to reach the full 60, which may or may not be necessary to enroll the planned 400 patients.
Most likely starting in August, I'll be checking the 'Recruiting' status. That should give us a great clue.
Best of luck with your investments!
Update: 51 sites recruiting / 60 planned as of yesterday
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Sacramento, California, United States, 95841
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Stuart, Florida, United States, 34994
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Albuquerque, New Mexico, United States, 87109
Liverpool, New York, United States, 13088
Rochester, New York, United States, 14620
Westbury, New York, United States, 11590
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Wake Forest, North Carolina, United States, 27587
Winston-Salem, North Carolina, United States, 27103
Edmond, Oklahoma, United States, 73013
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Best of luck with your investments!
45 out of 60 sites are recruiting
I keep an eye on the number of recruiting sites. The March presentation, slide 17, shows a planned number of recruiting sites at 60.
https://ir.outlooktherapeutics.com/static-files/cfa0c7ae-7b5e-4500-b21f-cc1a2243d2aa
As of the latest clinical trial update, March 29th, the number of sites was 45. 15 to go, or at the same cadence, about another month (45 sites in the first three months).
With the March presentation, the FDA timeline is in keeping with the previous PRs and presentations. And OTLK has a history of following timelines. So even if it does not unfold exactly as planned, I expect the timeline to be pretty close, maybe a month off but not 4 months for instance.
The rest of the presentation looks similar to previous ones, with more of a focus on European activities and money raises.
Best of luck with your investments!
Overall Planned MIlestones
Main point for the FDA resubmittal:
* Q3 full enrollment -> Q4 resubmittal
From the March presentation:
https://ir.outlooktherapeutics.com/static-files/cfa0c7ae-7b5e-4500-b21f-cc1a2243d2aa
Best of luck with your investments
Seeking Alpha: Positive Article
https://seekingalpha.com/article/4681360-outlook-therapeutics-de-risked-regulatory-tracks-are-lining-up-for-possible-ons-5010-approval
The article recaps most of the latest developments fairly well. I copied the conclusion below:
5 more sites added on 3/27/2024, now 44 sites
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Liverpool, New York, United States, 13088
Rochester, New York, United States, 14620
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Willow Park, Texas, United States, 79606
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Best of luck with your investments!
BTIG: $50 Target Price
https://www.marketbeat.com/instant-alerts/nasdaq-otlk-upgrade-2024-03-27/
A number of analysts are starting to up their price targets. I spaced up for better legibility:
now 38 recruiting sites!
Updated 2024-03-26. The sites:
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Oak Forest, Illinois, United States, 60452
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Liverpool, New York, United States, 13088
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Silverdale, Washington, United States, 98383
At this stage, a smidge over 10 patients by site would get OTLK to the target 400 patients. Plus a few more just in case.
The first sites were open for recruitment close to two months ago.
Best of luck with your investments!
Yes, end of May ! Thanks.
Bought another slide today, $8.06.
Best of luck with your investments!
.. 34 sites recruiting.
https://clinicaltrials.gov/study/NCT06190093#contacts-and-locations
Best of luck with your investments!
Looks like a wash?
The next logical news would be approval in a couple of month, say end of June.
Thanks! Link to the news on Nasdaq
https://www.nasdaq.com/articles/outlook-therapeutics-receives-positive-chmp-opinion-for-ons-5010-to-treat-wet-amd
Best of luck with your investments!
I hope you like the taste of dirt you blow tart
Post split news to dilute. Great short opportunity
Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD
Now 31 sites recruiting.
Beverly Hills, California, United States, 90210
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Liverpool, New York, United States, 13088
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Germantown, Tennessee, United States, 38138
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Silverdale, Washington, United States, 98383
Best of luck with your investments!
Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million
GlobeNewswire - 5:10 PM ET 3/18/2024 Investment News
ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting placement agent fees and offering expenses. Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.
The private placement was led by Great Point Partners, LLC, with participation from existing investor GMS Ventures as well as new investors Altium Capital, Armistice Capital, Caligan Partners LP, Schonfeld Strategic Advisors, Sphera Healthcare, Velan Capital, Woodline Partners LP, and an undisclosed life sciences dedicated investor.
BofA Securities and BTIG acted as co-placement agents in connection with the financing.
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