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I agree. Although this is also not impossible:
August - SAP was finalized
September - Data was locked
November - BLA was submitted
April - PDUFA date
In thinking about how Linda and Les have talked about trapping shorts with surprise, is it possible the SAP delay was exaggerated to give them time to unblind and submit their NDA. When was Dave from Merck hired? Might they already have a PDUFA date sometime in March?
You can practice patent law as a patent agent without going to law school. You just need to pass the patent bar exam. https://www.uspto.gov/learning-and-resources/patent-and-trademark-practitioners/becoming-patent-practitioner
Xena, before 10:03 and after 10:35, all the lots end in zeros. But between 10:03 and 10:35 you have these - odd lots in groups of 4, with each lot in the group of 4 triggering at 7, 22, 37, and 52 seconds after the minute. Can you break the code?
02/19/20 10:35:52 5.65 0.00 0.00 5,123
02/19/20 10:35:37 5.62 0.00 0.00 5,123
02/19/20 10:35:22 5.7431 0.00 0.00 5,123
02/19/20 10:35:07 5.7431 0.00 0.00 5,123
02/19/20 10:29:52 5.77 0.00 0.00 6,088
02/19/20 10:29:37 5.72 0.00 0.00 6,088
02/19/20 10:29:22 5.86 0.00 0.00 6,088
02/19/20 10:29:07 5.735 0.00 0.00 6,088
02/19/20 10:14:52 5.55 0.00 0.00 10,026
02/19/20 10:14:37 5.50 0.00 0.00 10,026
02/19/20 10:14:22 5.565 0.00 0.00 10,026
02/19/20 10:14:07 5.5302 0.00 0.00 10,026
02/19/20 10:12:52 5.56 0.00 0.00 12,534
02/19/20 10:12:37 5.51 0.00 0.00 12,534
02/19/20 10:12:22 5.60 0.00 0.00 12,534
02/19/20 10:12:07 5.60 0.00 0.00 12,534
02/19/20 10:10:52 5.67 0.00 0.00 5,675
02/19/20 10:10:37 5.58 0.00 0.00 5,675
02/19/20 10:10:22 5.67 0.00 0.00 5,675
02/19/20 10:10:07 5.62 0.00 0.00 5,675
02/19/20 10:09:52 5.6158 0.00 0.00 9,675
02/19/20 10:09:37 5.61 0.00 0.00 9,675
02/19/20 10:09:22 5.75 0.00 0.00 9,675
02/19/20 10:09:07 5.745 0.00 0.00 9,675
02/19/20 10:04:52 5.66 0.00 0.00 6,187
02/19/20 10:04:37 5.5724 0.00 0.00 6,187
02/19/20 10:04:22 5.66 0.00 0.00 6,187
02/19/20 10:04:07 5.59 0.00 0.00 6,187
02/19/20 10:03:52 5.58 0.00 0.00 5,146
02/19/20 10:03:37 5.5624 0.00 0.00 5,146
02/19/20 10:03:22 5.60 0.00 0.00 5,146
02/19/20 10:03:07 5.60 0.00 0.00 5,146
There has been talk on this board for a long time about LP and Les saying things about wanting to catch the shorts off guard with a surprise, or series of surprises. If that is their plan, then why would they telegraph a "very interesting" meeting happening 60 days from now?
After April 27th works in line with the ASCO Abstract dates. If they submit a Late-Breaking Data Abstract by March 12th, then the title of their submitted Abstract will be published on April 29th.
Abstract Dates to Know
https://meetings.asco.org/am/abstract-dates-know
Important Dates
November 6, 2019
Abstract Submission Open
February 11, 2020 at 11:59 PM ET
Abstract Submission Deadline
March 12, 2020 at 11:59 PM ET
Late-Breaking Data Submission Deadline
(Authors must submit a shell/placeholder by the February 11 deadline to be considered for Late-Breaking Submission)
March 27, 2020
Abstract Notifications Sent to First Authors
April 5, 2020
Abstract Withdrawal Deadline
April 29, 2020
Abstract Titles Released with iPlanner Launch
May 13, 2020 at 5:00 PM ET
Abstracts Released on ASCO Meeting Library
May 29-June 2, 2020
Chicago, IL
2020 ASCO Annual Meeting
Can you tell me how you get this type of information?
Although this sounds reasonable I think it's too conservative. If Rett data is positive, investors will be more likely to believe PDD data will be positive. And if PDD data is positive they will be more likely to believe Alz will be possible. So some portion of PDD value and Alz value will be priced into positive Rett results, and some portion of Alz value will be priced into positive PDD results.
M on the 2' chart
New 2-year high
There's no way you drop earnings and start a conference call after the market has opened unless you've got some really good news and some surprises to share.
Next up, Canadian copy-cat approval, then EP partner, then BO. Buy the rumor sell the news? There's still more news to come.
Can anyone explain this?
This morning when the bid was 0.2139 and the ask was 0.2150, I put in a bid for 0.2145. Didn't fill.
Moved it to 0.2146. No fill. Then 0.2147, then 0.2148, then 0.2149. No fill.
When I moved it to 0.2150 it filled instantly, but the price I paid was 0.2135, which is lower then the other bid still showing on level 2 and is lower than five bids I had entered previously. Any thoughts?
Now would be a great time for some trial progress updates and/or some patient/caregiver social media posts.
Highest daily volume in the last 52 weeks (not counting the day AVXL was added to the Russell 2000)
Health Canada decision due 11/29, correct?
On April 29, 2019, Amarin reported that the application had been submitted to health Canada and had been granted priority review status:
https://investor.amarincorp.com/news-releases/news-release-details/new-drug-submission-filed-vascepar-health-canada
Priority review status in Canada targets a decision in 215 calendar days: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html#a1.5
215 calendar days from April 29th is November 29th.
Of course, the application could have been submitted before April 29, 2019, that's just the day they told us it had been submitted.
"Missling's comment that "you will understand why we did it this way when the news comes out" keeps ringing in my mind."
Please remind me when he said this, in what context?
Here's an example where the PDUFA date was on a Sunday (10/15/17) but the approval was announced on Friday (10/13/17). Does anyone know whether this is FDA's standard practice?
https://www.drugs.com/newdrugs/janssen-announces-fda-approval-stelara-ustekinumab-adolescents-moderate-severe-plaque-psoriasis-4613.html
Seems like the FDA tends to issue approvals on the PDUFA date:
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019
But what do they do when the PDUFA date is on a weekend, like this one?
If you search her name, it lists the 10 abstracts she is an author on.
From the 11/19/19 PR: "The upcoming stages include finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data. Each of these are multi-month processes, and will involve tremendous work by both our team and teams of outside experts. In addition, virtually all aspects of the Company's work involve pioneering."
I would've been very surprised to see all these stages completed by now, so I don't see how some think the top line data is behind schedule.
Hi Biostockclub. How has the Rett probability changed since the Rett data announcement?
The URL contains "/2018/05/" so I'm thinking it was uploaded May 2018.
Where's your link for that? Or just your opinion? So you're saying that the FDA sees cancer as a devastating illness with inadequate treatments and so applies different standards? Clearly you don't have anyone close to you with ALZ.
Here are two example approvals using biomarker-positive subgroup analyses:
"For example, cetuximab was approved for metastatic colorectal cancer based on a phase III RCT that enrolled all patients and retrospectively assessed tumor biopsies for KRAS mutations 28, 29. Treatment was effective for patients with KRAS wild-type tumors (progression-free survival HR?=?0.57; 95% CI, 0.36–0.91) but not for those with KRAS-mutated tumors (HR?=?1.83; 95% CI, 1.10–3.06, p(interaction)?=?0.001)."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537292/
"An example of a non-significant treatment-by-biomarker interaction in the pivotal RCT is lapatinib, for treating metastatic breast cancer that overexpresses the human epidermal growth factor receptor 2 (HER2), combined with letrozole. Data supporting this indication were derived from a double-blind RCT. Among 1286 randomized patients, 219 (17%) were HER2-positive and benefited from lapatinib (disease progression HR?=?0.71; 95% CI, 0.53–0.96), with no benefit demonstrated for HER2-negative tumors (HR?=?0.90; 95% CI, 0.77–1.05)"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537292/
So you're saying that if the primary outcome measures are met for the entire study population, then the data can be used.
But if the primary endpoints are met for the marker positive subgroup (about 80% of them), but are not met for the marker negative subgroup (a built in negative control group), then the FDA will just ignore the data showing efficacy in an easily identifiable subgroup and just let 80% of ALZ patients continue to go untreated. Doubt it.
"There's no specific screening criteria that would limit the patient population in any particular way compared to other failed trials."
Actually, yes there is, at the link you provided under other outcome measures:
"4. Number of participants with pre-specified genetic variants [ Time Frame: 48 weeks ]
AD relevant pre-specified genetic variants will be assessed. Statistical testing of treatment differences within subgroups will be performed"
So the can assess all the primary and secondary outcome measures within each of the subgroups.
We need to find a caregiver posting on social media about their family member trial participant.
Nasdaq's minimum share price is $2, or $3, or $4, depending on other criteria. https://www.investopedia.com/ask/answers/nasdaq-listing-requirements/
As I understand it, that is their working theory. But if it's true, the beneficial effect is likely not unique to ALZ patients.
CM sounded much more enthusiastic about the pace of enrollment of all the trials then the PR this morning did.
He said they are on track to release top-line Rett study data by the end of this year.
I called in by telephone. Started on time.
No, started on time
Since the Q&A portion of the call appears to include only analysts, can we send questions to the analyst before the call to let them know what we want to know? Do you know who the analysts were that were on the last call?
Although there was no placebo in the 2A they found and have reported a positive correlation between response and blood concentration levels. Since the patient/caregiver can't know their blood concentration level, a positive correlation between response and blood concentration is enough to rule out a placebo effect.
Rett Recruitment?
AU
2 sites recruiting 30 patients.
First patient dosed June 6th (49 days ago).
Today, they need just one more (according to the Facebook post).
US
3 sites recruiting 15 patients
First patient dosed March 18th (129 days ago).
Today they need ??
AU has had less than half the time to recruit twice as many patients from 2/3's the sites as the US.
Can't imagine why AU would be (almost) done recuiting, but the US is still not.
Or the US is done but the announcement has not been made. If it were me, I would delay as long as legally possible announcing that enrollment was complete. As soon as that announcement is made, investors/traders calculate the last date of the last dosing of the last patient, and then start worrying about why the data hasn't yet been released. Delaying the enrollment complete announcement builds in the needed time at the end to do the analysis before announcing the top-line results. I think the US is done recruiting, and perhaps they're done dosing (129 days - 49 days = 80 days or 11 weeks) and perhaps they've already started the analysis. They'll wait till the AU is fully enrolled to announce that both trials are fully enrolled. And then the US results will look to be released earlier than expected.
Something's up?? After-Hours
Most Active in the After-Hours
After Hours Time (ET) After Hours Price After Hours Share Volume
17:07:23 $ 2.90 High 2,980
17:07:17 $ 2.90 High 20
17:07:17 $ 2.80 20
17:06:54 $ 2.77 50
17:06:54 $ 2.75 100
16:32:24 $ 2.64 2,834
Nasdaq.com
Those are positions as of 03/31. It states so right after the number of shares.
Agreed, and they're being really really low key. If they wanted to just pump up the share price there is plenty more they could be doing. But they're not yet and I wonder what is the plan.
Steady T
"Although including a placebo group in dose-response studies is desirable, it is not theoretically necessary in all cases; a positive slope, even without a placebo group, provides evidence of a drug effect."
See page 9:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073115.pdf