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May! Here is to good news before the end of the month.
The March 22nd PR stated that:
Me too, been 'Long' over ten years, and definitely not selling shares now that we are this close. Once the submittal was official, there was no way I was going to sell a single share. Confidently hopeful.
Best of luck with your investments!
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!
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!
Thanks someconcerns
That follows what they announced on March 18:
$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!
Holtec deal & potential NuScale fallout
https://www.reuters.com/business/energy/holtec-gets-152-bln-loan-us-restart-nuclear-power-plant-2024-03-27/
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!
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!
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!
With pre-commercial biotech, it's hard to know what's going on behind the scenes.
I went back to the Feb 2024 presentation, and if the EU/UK does approve in H1 as hoped by management (or later), that market looks like a great commercial opportunity:
Given today's PPS, it could be simply getting back to a baseline PPS (say around $10 post reverse split) or some 'rumor'. Anyways, I keep being hopeful for the medium term (6 month/2 years) for this investments.
Best of luck with your investments!
From the CC, a couple of snippets from John Hopkins.
One way to understand SMR:
A few more recruiting sites
California Locations
Beverly Hills, California, United States, 90210
Modesto, California, United States, 95356
Poway, California, United States, 92064
Florida Locations
Jacksonville, Florida, United States, 32216
Minnesota Locations
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Mississippi Locations
Jackson, Mississippi, United States, 39202
North Carolina Locations
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
South Carolina Locations
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
Texas Locations
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
Utah Locations
Salt Lake City, Utah, United States, 84107
Virginia Locations
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Washington Locations
Silverdale, Washington, United States, 98383
See: https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1#contacts-and-locations
Best of luck with your investments!
CC Thursday March 14, 2024, at 5:00 p.m. ET.
From the proxy material:
OUTLOOK THERAPEUTICS, INC.
2024 Annual Meeting
To be held Thursday, March 7, 2024
(I am not seeing the in-person address, not that I intend to attend in person).
Best of luck with your investments!
Recruiting Sites: Starting to look the part
I do not believe this is all the sites which will end up recruiting; However, it's starting to look better
See: Contacts and Locations
https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1
how would you rank our paid bashers?
* Silver Tongued Devil
* Serpent
* Pitchfork
Ex, LC, Inquirig, etc. ??
This company tells us what they plan, the expected dates, and they keep executing. The communication is clear and to the point. It's in their DNA, they have been practicing this under Russ T.
I like this type of leadership and how shareholders are informed.
Best of luck with your investments!
Russ Trenary on the progress since the CRL:
Updated Anticipated Milestones
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-first-quarter-0
Upcoming Anticipated Milestones
Second Recuiting Site: Utah / Salt Lake City
On Feb. 5th, the clinical trial site was updated to indicate a second trial site in "Salt Lake City, Utah, United States, 84107"
Before that, one site was indicated in "Dallas, Texas, United States, 75231"
That's 2 sites that came up online pretty quickly given the January 23 SPA announcement and the first subject only one week ago! OTLK does not lose time.
For comparison,
* Norse 7 had 3 sites
* Norse 3 had 20 sites
* Norse 2 had 39 sites.
"The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. "
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license
So I expect a lot more sites to come online for this study, but I don't know how many to expect. OTLK does forge ahead and I would not be surprised if that number keeps on moving up for the next couple of months. They keep executing!
Best of luck with your investments!
Thanks abeta. The p-values are telling!
First Subject in NORSE EIGHT
After the SPA, after the clinical trial publishing on clinicaltrials.org, after the change of status to recruiting, this step indicates the continued progress of the Company towards their goal.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-doses-first-subject-norse-eight
Hi Zadie420,
Would you have the clinical trial link to this specific study?
Thanks
Best of luck to Patients, NWBO, and Longs!
Now recruiting, Study Completion Expected Oct.
https://classic.clinicaltrials.gov/ct2/history/NCT06190093?B=2&A=1&C=merged#StudyPageTop
Best of luck with your investments!
Clinical Trials Site for Norse 8:
https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1
Not recruiting yet. A good site to check from to to time and see the progress.
Best of luck with your investments!
NORSE EIGHT :
The FDA SPA agreement is in!
I keep being impressed with management clarity on planning, deadlines, and execution!
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-501