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Wonder where we are in Central Park?
where they can use it to shop for a buyout prior to PRing it
Give some a preferential view of the data prior to releasing to the public?
That doesn't necessarily mean those shorts were held short when the trading day ended.
With algo's and HFT many of these trades are held less than an hour.
It's that third arm that mucks up the scenario
Original design
Arm SOC - 3/7ths of total candidates
Multikine Arm - 3/7ths of total candidates
FDA arm (no zinc tabs) - 1/7th of total candidates
Evaluable participants needed at end of trial = 784
Conveniently 784 divided by 7 is 112
The two comparative arms need a minimum of 336 (112*3) at end of trial to maintain statistical power.
The original design called for 377 enrollments in each of the two comparative arms. The designers factored in a 10% increase for drop out purposes. 2013 Laidlaw report pg 15
The final enrollment in each of the two comparative arms, due to the 'additions' courtesy of Geert (circa 2016) total near 400.
Those additional 48 provided a greater buffer for dropouts, not a bad idea considering the length of the trial, even in 2016.
But 40 of the additional 48 were added to the comparative pool. Thus allowing 40 additional patients who's deaths could shorten the time of the trial to reach 298 events.
And the End point was not adjusted. Still it took many additional months to arrive at 298 than most anticipated.
Don't have private posting privilege
Just throwing it out there meirluc
Actually this has been discussed a number of times.
The idea that every clinical trial has a plethora of drop outs has been foisted upon the unknowing populace by indirect advertisements for clinical trial companies.
Here, here!
Geert has guided this thru incredibly challenging events.
Would rank him in the top five of leaders.
Dangerous waters there...
See Geert guided by two passions...
One, the science.
Two, disgust with the shorts.
Can see him pulling a rope-a-dope and setting up the anticipation for April 15 as the Data Day. (D-Day for shorts)
Only to drop the Data Before that date to ensnare them.
But he needs to not overstep the regulations and put the approval process at risk.
The "Completion Date" is when the last patient has been evaluated for all endpoints.
When was that, when the last patient was evaluated...?
Clinical trials website for this particular trial, from April 2020 until Mar 17, 2021 for the Study Completion showed May 15, 2020.
Then on or about March 17, 2021 the Study Completion date was changed: at the Sponsors request to: April 15, 2021.
Why this date change at this time?
Data has been locked since last year, cannot be any more patient evaluations.
Clinical Trials dot org is an FDA regulated entity
The requirement to update is regulated...federal register
The final rule also lists Study Completion Date as a required registration data element under §?11.28(a)(2)(i)(U) and specifies the data element definition in §?11.10(b)(41) as “the estimated or actual study completion date. Once the clinical trial has reached the study completion date, the responsible party must update the Study Completion Date data element to reflect the actual study completion date in accordance with §?11.64(a)(1)(ii)(J).” We have included the study completion date as a component of clinical trial registration information in accordance with the statutory authority in section 402(j)(2)(A)(iii) of the PHS Act, which permits the Secretary to “modify the requirements for clinical trial [registration] information” by regulation, provided that “such a modification improves and does not reduce such clinical trial information.” We believe that Study Completion Date is helpful to indicate to the Agency, responsible parties, and the public when all primary and secondary outcome measures and collection of all adverse event information, as specified in the protocol, will be completed and when final data collection for all primary and secondary outcomes and all adverse events has occurred.
As with regulatory agencies - the wording is incredibly obtuse. But the gist seems to be that once the primary study completion date is known and the study is coming to the completion of all data compilation the Study Completion Date should reflect an educated understanding of when the Study will be complete.
definitions from the clinicaltrials website
It is interesting to note that CVM was placed on the FDA's SRO (Significantly Regulated Organization) on the same date at the Clinicaltrial site was updated.
Did the SRO administrator just pick this up?
Was there communication from the Sponsor?
The Sponsor was confident enough in the date to generate it's posting.
Interesting times.
how many small cap bios with a pre data readout
TESARO is a commercial-stage biopharmaceutical company, with a major marketed product, Zejula (niraparib)
Eli Lilly (NYSE:LLY) shares finished Monday on a slightly positive note after the company announced an agreement to acquire Loxo Oncology (NASDAQ:LOXO) for $8 billion in cash. That's not an outrageous sum to pay for a biotech that's already earned its first FDA approval,
Celgene will make an upfront payment of $1.1 billion for the privately held San Diego company, Impact Biomedicines, the companies said in a statement Sunday, confirming an earlier report in The Wall Street Journal.
Assuming Impact hits regulatory-approval milestones, another payment of as much as $1.4 billion could be forthcoming, the companies said. Should global net sales surpass $5 billion, there could be another payment of as much as $4.5 billion.
Celgene Corporation (NASDAQ:CELG) and Juno Therapeutics, Inc. (NASDAQ:JUNO) today announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Juno. Under the terms of the merger agreement, Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies.
Celgene and Juno entered into a strategic collaboration in June 2015 under which the two companies would leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on CAR T and TCR technologies. In April 2016, Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China.
(Do any Big Pharma's own shares in CVM?)(Or collaborated with them for three years?)
Gilead Sciences' (NASDAQ:GILD) planned $11.9 billion acquisition of Kite Pharma (NASDAQ: KITE) nets it axi-cel, a CAR-T therapy that's already under FDA review.
Kite Pharma has 14 clinical trials ongoing or planned targeting 10 cancer indications.
CVM has, uhmm two.
There may be a difference of opinion in what exactly is a pre-data readout scenario.
I bow out of this thread.
Yes sir! ma'am?
Appreciate all the examples you shared in your post.
Thoughts on the end game.
Timeline:
1. Full Data Readout - April
2. Money raise ( within three weeks of FDR)
3. BLA submission - Nov 2021
4. FDA acceptance - Jan 2020
5. PDUFA date - Oct 2022
Narrative
1. GK seems so fixated on shorts - can see a FDR before April 15.
2. They need money - having money is not a bad thing when negotiating a BO.
3. Small shop biotech with no one on staff who has filed a BLA. Easy six to eight months until filed.
4. FDA has seventy days to accept the filing.
5. 10 months from acceptance to PDUFA.
BO probability
1. 2% - who is going to commit $ Billions to a drug without a clear certain path to FDA Approval. Their CMO hasn't even been able to review data.
2. 0%
3. 5% BLA filing - still not accepted by the FDA.
4. 5% FDA acceptance does not guarantee approval.
5. 65% Once the approval process is past the Late Cycle Meeting and there are NO issues.
CDER 21st Century Review Desk Reference Guide
6. After approval 23%
What does it matter who the shorts are now?
Shorts hinder biotechs from raising money, when they don't have a pipeline deep into the approval process.
Cel Sci is beyond that.
Next raise will be after successful Phase 3 data.
2 million shares at $50 or more a share.
What does it matter who the shorts are?
That should no longer be his concern.
He should be interviewing candidates to help with the BLA filing.
Candidates who have walked that trail before.
Shorts are a part of the history, nothing more.
Has anyone reached out to IR of Cel Sci
To ask why the sudden interest in updating the clinicaltrials.org website?
Tweets holding at 243
Is there a message in that number?
Your Numerology Chart
Discover how the numbers add up for you
Let's see: Full Data Readout (FDR) who held the Presidency for 3 full 4 year terms and 2 years into the 4th. 2 + (4x3)
Feb 7 - No
Jun 3 - Hmm! (2+4=6 which is June)
Cancel the 2 leaves April 3.
24.3 % OS in the Multikine arm?
$243 a share at the BO?
Amateur numerologist on a home course - you may try this at home.
WHSmith great blog appreciate the hard work.
Just a thought on the market penetration from the Hard Asset Conference presentation on the Cel Sci website.
Geert figures 60,000 cases annually in the US and 105,000 in Europe.
"If it's standard of care, you usually expect 75% of market penetration."
Timestamp: 12:55 into the presentation until 14:10.
May 2019 Hard Asset Conference May 2019
The OS from the Multikine arm in Phase 2 trial had a limited sample pool.
"Documented data were available for 19 of the 22 patients in the follow-up portion of this clinical trial."
"The median overall survival (calculated by including death from any cause of patients in the trial, even deaths not related to the disease) of the 19 evaluable patients in the follow-up portion of this clinical trial was 63% at a median follow-up of 40 months post-surgery."
19 participants represents the OS pool.
Each participant moves the needle 5%.
How crazy is that.
Isn't it possible a higher (as well as a lower) OS than 63% could be had with a larger OS pool?
In this group of 19 -
2 had complete response -
2 had greater than 50% reduction in tumor and
4 had a minor response.
In this study of 12 patients, two had a complete response.
This was a 10 day injection regimen.
And the great unknown is the elimination of the source of the micrometastasis, which should reduce the recurrence of HNSCC.
There is something afoot.
The Original CRO was in the process of being bought in 2012. In Feb 2013 Geert lowered the boom on the CRO.
Businesswire news story
CEL-SCI Presents Long-Term Survival Data With Its Anti-Cancer Drug Multikine(R)
Link to Biospace article
Neoadjuvant Immunotherapy of Oral Squamous Cell Carcinoma Modulates Intratumoral CD4/CD8 Ratio and Tumor Microenvironment: A Multicenter Phase II Clinical Trial
Link to the publication
The last Phase 2 trial:
Don't think people appreciate the road that took.
Three consecutive road wins during the playoffs.
Go CVM!
Okay
Some just aren't that quick with a calculator. :)
The 40,529,278 million share count is taken on Feb 5. (10Q)
Share count: BALANCES AT DECEMBER 31, 2020 = 39,767,058
How did you account for the difference of 762,220 shares from 12/31 to 2/5
Probably some warrants were 'exercised'.
Thesis: $20 Billion Buy Out 51.6 million shares - $387.59
$20 Billion Buy Out 52,446,545 shares - $381.34
How's FL with that Super Bowl win?
Great posts - solid questions
CTE - some of the trials involve the use of a placebo.
Disguises to the participant whether or not they are taking the real test drug.
The psyche of the participant is an intricate part of his being. John Doe
feels positive about the situation - body's glands, etc. actually work better.
John Doe has also been selected to be part of an important medical study that could benefit everyone who ever gets afflicted with the disease, condition, etc. that he, John Doe has.
How many groups, fellowship, societies, support groups are there whose sole point of commonality is the disease, condition, etc they have?
John Doe's life now has a purpose, a reason for being.
This, I believe is a source for the CTE.
To the trial at hand, there was no placebo.
Yes, Cel Sci bought the entire health care package for every participant. Make a level playing field, otherwise the results could be discredited.
Look at the post SOC trial care - routine check ins from the medical professionals.
Which doctors get to be selected to participate in clinical trials? Surely not the doctors that are a year past their internship.
Experienced, practised.
There are a lot of medical professionals invested in the trial participants well being.
Enough to give one's life, meaning - the one that is on the receiving end of that care.
This is part of the source for the CTE. One's life has value.
Thanks
This is most likely my last ride on the Phase 3 read out roller coaster.
Future investments will favor the bios with good PDUFAs results just waiting on the buyout.
Although I hold some RLMD - incredibly fast acting adjunct med in treatment for depression. Stellar phase 2 results and just starting phase 3. See a $10 - $15 billion buyout on good phase 3 results in couple of years. Probably 20 -25 million shares at the BO.
IMMU was nice.
Hold some AUPH, looking at MYOV.
Have bought a lottery ticket with RECO (otc: RECAF) drilling into a undrilled basin in Namibia for Petro.
The art of writing Clinical Study Reports
EMWA is the European Medical Writers Association, a network of professionals that represents, supports and trains medical communicators in Europe. It is a not for profit organisation that is run for its members by its members. This website offers access to EMWA's journal Medical Writing, ...
A past president of the organization writes: RE: Clinical Study Reports
This will probably be my last 'investment' in a phase 3 results aka binary event biotech.
We can do all the DD imaginable - but that doesn't translate into a sure thing.
Take BLUE for example -
Yes that is fine
Appreciate your kind words!
Most of what I post is cut and paste from sources.
No, not on Reddit.
Results Information Submission
Clinical Trials Registration and Results Information Submission
Results Information Submission
This final rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA. It also extends the requirement for results information submission to applicable clinical trials of drug products (including biological products) and device products that are not approved, licensed, or cleared by FDA. The rule requires the submission of data in a tabular format summarizing participant flow; demographic and baseline characteristics; primary and secondary outcomes, as well as results of any scientifically appropriate statistical tests; and adverse event information. In addition, the rule requires the submission of the full protocol and statistical analysis plan (if a separate document) (see Section III.D).
In general, this rule requires the submission of results information not later than 1 year after the completion date (referred to as the “primary completion date”) of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.
This rule also permits responsible parties to request extensions to the results information submission deadlines for “good cause”
Edit: Presume collecting data amidst a world wide pandemic would be defined a "good cause"...
With Cel Sci being the trial sponsor of Phase 2
could they continue to follow the trial participants? into the 2010's
Meaning, Cel Sci would have additional info and understanding that isn't published.
Geert recently mentioned a participant in the TEVA run trial that has been alive over 15? years with a tumor but it has progressed no further.
One of the benefits of bringing in trial partners like TEVA is the ability to access information from them.
The Effect of Leukocyte Interleukin Injection (Multikine®) Treatment on the Peritumoral and Intratumoral Subpopulation of Mononuclear Cells and on Tumor Epithelia: A Possible New Approach to Augmenting Sensitivity to Radiation Therapy and Chemotherapy in Oral Cancer—A Multicenter Phase I/II Clinical Trial†
The Laryngoscope - December 2003 ncbi link
József Tímár and Eyal Talor
Here's a link to study published in 2002
Improved survival with perilymphatic interleukin 2 in patients with resectable squamous cell carcinoma of the oral cavity and oropharynx
A total of 220 patients with SSC of the oral cavity and oropharynx who were recruited between May 1990 and December 1996 were assigned randomly to receive rIL-2 and surgery (plus radiotherapy, when necessary) or surgery alone (plus radiotherapy, when necessary).
The clinical trial effect
Two types of trials, of course there are more..
(Open Label) One where the participants know they are not receiving the test drug.
(Double Blind) One where the participants don't know if they are receiving the test drug.
The application of Multikine, by injection, does not ethically allow for a Double Blind trial setup.
Who wants to inject a placebo, if that's even possible into H&N tumor area for three weeks?
The individual being treated in a double blind trial that receives the placebo, his psyche is influential in his improvement.
What happens to the trial participant in Open Label trials where they know at the outset they are NOT receiving the test drug?
Wouldn't they be bummed?
Asking for a friend...
Lots of articles about surrounding the idea
Oncology study
True that
JC was not focusing on any one company.
And with all due respect to GK, just because the company being shorted is involved with a cancer drug trial doesn't make being short a moral calamity.
For most who short biotechs involved in cancer drug trials it's all about the percentages and risks. Nothing to do with 'hoping' the cancer drug fails.
Twitter does make for interesting exchanges....
Could be a target
Claims (46)
48 Things Medical Writers Need for Clinical Study Reports (CSRs)
Blog for Medical Writers
This list is a reflection of my experience directing medical writing departments and doing medical writing since 1995. The information in this post isn’t intended to be definitive. Each individual clinical study may require documents that I haven’t mentioned here; conversely, some studies won’t require some of the document types that I’ve listed. Consult the relevant regulatory guidelines to verify the kinds of documents required for preparing your ICH-compliant CSR.
Dr Caldwell has headed 5 medical writing groups at various companies since 1995, and has done a lot of regulatory medical writing. Susan is also a published author, with numerous articles in the peer-reviewed medical literature. She has been a consultant medical writer since 2005, and works in the Greater Seattle area,
Maybe contact the good Doctor and ask about the writing process and timelines.
Jan 31, 2021 early on a Sunday morning - Geert is tweeting about how he can't sleep - how excited he is that his life's work, it's vision, is finally being realized.
Wonder if there was some info about where the CRO was in the CSR process that prompted this overflow of synapses in his brain?
Hmmm.
Full Data release:
July? No it will be before July.