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Fair enough...
It’s also been suggested the heroic actions of FDA physician Dr. Frances Kelsey, who single handedly blocked the approval of thalidomide use is the US, after the drug was approved with devastating birth defect consequences in Europe, left a lasting impression on the FDA’s extremely conservative mindset.
Critics of the FDA’s years long, crushingly expensive trial regimen have offered alternatives to speed up access to new medical solutions by suggesting Phase I and II testing be used to establish dosing parameters and safety. Phase III would be supplanted by making new promising drugs, deemed to be safe, conditionally available to doctors who agree to closely track and confirm patient efficacy and outcomes.
This approach places high degrees of trust in doctors to follow drug administration protocols, but would expand and speed up patient access. The current FDA approach, at a minimum, deserves honest process improvement scrutiny.
G.B.
It’s called kissing the FDA bureaucrats ring to validate they were so wise in slapping on the Hold and keeping it in place until ADXS saw the light, admitted the error of their ways and agreed to modify some procedure or process.
It’s entirely possible and perhaps likely based on its history AZN Imfinzi was the trigger that pushed the stage 4 patient over the edge. AZN was likely indifferent to resolving the issue because resolving the Hold didn’t matter to them.
A months long Hold based on the circumstances we have available did nothing to serve the advancement of medical research or, in truth, the public interests. Holds do provide opportunities for the FDA to flex and message their own importance.
I appreciate the FDA has defenders on the MB. Obviously, I’m not one of them.
G.B.
The referenced initiative is a splinter effort by Dr Mason’s team at UPENN started after ADXS indicated they were de-emphasizing or shelving HER2 efforts. She announcing the program involving an 80 dog trial funded by the Morris Group grant last year. I think she’s a true believer in HER2 potential and likely didn’t agree with it being dropped by ADXS. She also indicated the new effort would hopefully support future efforts to target osteosarcoma in children using a HER2 construct.
Her initial HER2 research landed the Aratana deal. It would be great if she knocked it out of the park with this larger canine trial.
G.B.
BP’s like AMGN or MRK aren’t likely to extend charity or weigh in to save a small biotech in dire straights. Particularly If they covet the Intellectual Property, (I suspect they do) they will just let nature run its course and negotiate with whoever holds the rights to the science after ADXS craters. It not a bad strategy. Gets rid of the BOD and incompetent management along with all the financial rewards and obligations they had shamelessly voted themselves. It would also presumably negate or reopen the bad licensing deals the company negotiated.
If I’m AMGN observing the rapid financial decline, I’m just biding my time and developing a plan to pick up the pieces. This may ultimately be the best shot the Lm platform has for success.
Hope my take is wrong.
G.B.
Selected excepts from ADXS IR... A significant number of collaborations, regulatory endorsements and shots on goal over 11 years to arrive at our current 2 or 3 product standing with AXAL(?), NEO and HOT. Many of the earlier initiatives appear to have just evaporated into the ether as they haven’t been referenced by ADXS in years or I assume exist in some form of suspended animation. As a small biotech with limited funding - hindsight might suggest ADXS was overly ambitious and spread themselves very thin with too many non or under funded initiatives they’ve now suspended.
Very unfortunate as many of the products they’ve been forced to abandon appear to have important medical potential. I hope they’ve chosen the remaining product portfolio wisely. The companies complete IR history back to 2007 is painful to review. Its interwoven with early scientific promise as well as managerial greed and numerous operational missteps and over-reach. G.B.
Advaxis Announces Dosing of First Patient with ADXS-NEO, an Investigational Customized Immunotherapy Approach Targeting Personal Neoantigens
Jun 11, 2018
Advaxis Submits Conditional Marketing Authorization Application for Axalimogene Filolisbac for the Second-Line Treatment of Metastatic Cervical Cancer in European Union
Feb 13, 2018
Advaxis and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate ADXS-DUAL and Opdivo (nivolumab) in Metastatic Cervical Cancer
May 30, 2017
Advaxis and SELLAS Announce Licensing Agreement for Development of WT1 Antigen-Targeting Immunotherapy
Feb 27, 2017
Advaxis’ Axalimogene Filolisbac to be Developed and Commercialized in Latin America With Stendhal
Feb 3, 2016
Amgen And Advaxis Enter Global Cancer Immunotherapies Collaboration
Aug 2, 2016
Advaxis’ AXAL Receives Fast Track Designation by the FDA as Adjuvant Therapy for High-Risk Locally Advanced Cervical Cancer Patients
Jul 21, 2016
European Medicines Agency Committee Classifies Advaxis’ Axalimogene Filolisbac as an Advanced-Therapy Medicinal Product
Jul 18, 2016
FDA Grants Special Protocol Assessment to Advaxis’ Phase 3 Study of AXAL in Patients with Cervical Cancer
Jul 6, 2016
FDA Grants Advaxis Fast Track Designation for ADXS-HER2 for Patients with Newly-Diagnosed, Non-Metastatic, Surgically-Resectable Osteosarcoma
Apr 28, 2016
Advaxis Receives Orphan Drug Designation in the European Union for Axalimogene Filolisbac for the Treatment of Anal Cancer
Dec 14, 2015
Advaxis Receives Orphan Drug Designation in the European Union for ADXS-HER2 for the Treatment of Osteosarcoma
Dec 1, 2015
FDA Awards Grant for Phase 2 Study of Axalimogene Filolisbac (ADXS-HPV) in HPV-Associated Head and Neck Cancer
Sep 14, 2015
Advaxis Announces Licensing Agreement With Knight Therapeutics and Raises $25 Million Through Direct Investments From Knight and Sectoral Asset Management
Aug 26, 2015
Advaxis Announces FDA Clearance of Investigational New Drug Application for Phase 2 Study of ADXS-HPV and Incyte's epacadostat for the Treatment of HPV-Associated Early Stage Cervical Cancer
Jun 1, 2015
Advaxis and Sorrento Form Collaboration to Evaluate Combinations of Advaxis's Lm-LLO Immunotherapy Technology and Sorrento's Immunomodulatory Antibodies
May 19, 2015
Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence Clinical Trials of ADXS-PSA in Combination With Merck's KEYTRUDA(R) (pembrolizumab) for Prostate Cancer
Dec 8, 2014
Advaxis Submits Investigational New Drug Application for Phase 1/2 Study of ADXS-HPV and MedImmune's MEDI4736 for the Treatment of HPV-Associated Cervical and Head & Neck Cancer
Nov 12, 2014
Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer
Aug 25, 2014
Advaxis to Ring The NASDAQ Stock Market Closing Bell
Mar 26, 2014
Advaxis and UC San Francisco to Evaluate Cancer Immunotherapy Constructs in Prostate Cancer
Mar 17, 2014
Advaxis Signs Exclusive Licensing Agreement for Development and Commercialization of ADXS-HPV in Asia
Dec 9, 2013
Advaxis Awarded Best Therapeutic Vaccine
Apr 12, 2012
Advaxis Announces Collaboration with Wistar Institute
Apr 14, 2011
Advaxis India Cervix Cancer Trial Begins Dosing
Nov 24, 2010
Advaxis Enters into Collaboration with the University of British Columbia
Nov 8, 2010
India Approves Advaxis Trial in Cervix Cancer
Sep 22, 2010
Advaxis Signs Agreement with Cobra For Manufacture of Lovaxin C Vaccine
Oct 18, 2007
NY... Greatly appreciate you sharing scientific research and interesting datapoints. For we layman, would be helpful if you could include just a line or two on why the information may be relevant or can be linked to the ADXS Lm platform.
Thanks,
G.B.
Feels like we’re officially in an end game boom or bust trajectory. I added a few hundred shares today assuming I was throwing good money after bad or I was getting the steal of the century.
G.B.
Speaking of our friends at AMGN...
https://www.marketwatch.com/story/investors-love-amgens-buybacks-if-not-its-growth-2018-02-02
As the attached article from earlier this year notes, like many other BP’s, they really need to add juice to their aging pipeline. They certainly have the means to do so. They had more offshore capital available to repatriate than any other pharma company or roughly $34B. Further, as noted, they have $70B in overall deal making capacity. Extending their investment in ADXS to include HOT or even buying the company outright would be a rounding error on their balance sheet.
Instead of pulling the trigger on acquisitions, they’ve authorized over $14B in stock buybacks this year. Typically a sign of a company that is defaulting to buying back stock in the short run to make their shareholders happy. With that war chest and an aging product set, AMGN longer strategy has to include material acquisitions of new medical technology that fit within AMGN’s biocentric product portfolio.
Stock buybacks aside, ADXS is such a small fish it’s hard to believe AMGN won’t snatch them out of circulation the instant they’re convinced NEO and HOT are the real deal. Feels like our fate now rides with that determination.
I remain foolishly committed and cautiously optimistic.
G.B.
Listed acquired shares for 3 BOD members appear to be a vesting action from previously awarded RSU’s or grants as the transactions reflect $0 as the purchase price. At least that’s how they are reflected on my stock monitor.
I’d be happier if they were actually picking up shares via personal out of pocket purchases.
G.B.
ADXS Lm linkages to peptide immunization is referenced in the recent AACR poster presentation materials.
The first study, as discussed in a poster presentation at AACR entitled “Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform,” showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as “non-immunogenic” using a conventional peptide-adjuvant immunization. The poster is available here:
https://www.advaxis.com/wp-content/uploads/2018/05/ADXS-NEO-Lm-immunogenicity-AACR-poster_Final.pdf.
These preclinical findings provide foundational rationale suggesting that ADXS-NEO has the potential to generate immune responses against multiple neoantigens with the ability to control tumor growth. This is a personalized approach that uses a patient’s own immune system to recognize and eliminate cancer cells harboring multiple mutations that caused their malignancy,” said Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. “We also saw potent immune responses targeting frameshift mutations and control of tumor growth via multiple complementary mechanisms. This is important because frameshift mutations are observed to generate up to nine times more neoantigens per mutation than in-frame mutations” according to Turajlic, et al.
Positive NEO Lm implications that relate to NY1972 peptides (frameshift) scientific heavy post. I think.
G.B.
I'm always surprised and bemused that anyone can muster a defense of the FDA and their bureaucratic strangle hold on the drug approval pipeline. We won't even go into BP favoritism. Let's at least start honestly capturing and counting lost patient benefits and deaths while waiting during years of trial requirements and see how the FDA fares.
We both know common aspirin would struggle to get past current FDA regulatory hurdles.
We obviously have very different views and opinions about the FDA which is ok. You're entitled to your opinions, as am I.
G.B.
Perhaps the FDA has a dilemma...
They’ve got a favored BP son with FDA approved Imfinzi constructs being applied to patients at $15,000 (wholesale pricing) per month on one side of the Hold and a no name biotech hanging by a financial thread on the other half of the transaction. They’re likely very aware ADXS isn’t culpable in the patients death since they’ve seen first hand the effects Imfinzi can have on patients with advanced stages of disease and require AZN to list death as a possible Imfinzi side effect.
If the FDA implicates Imfinzi, how do they rationalize not putting all Imfinzi products they’ve already approved on hold? I doubt they care about any guilt by association impacts the Hold is having on ADXS.
Not to be callous, but it’s bad enough trials are skewed to predominately include the sickest of the sick who have not responded to other treatment options, but then the FDA throws up more barriers by implementing snap holds when there’s a death of a late stage patient. They then put the targets of the hold through a huge data collection and analysis exercise followed by months, in some cases, to render judgement.
The FDA Hold process looks very much like a CYA exercise to cover the FDAs ass at the expense of new drug development speed and availability of new drugs for sick patients. The newly approved National Right to Try legislation should be viewed as exactly what it is, a slap in the face of FDA bureaucracy and intransigence.
G.B.
Encouraging to see insiders buying, particularly a couple of the BOD members...no matter what prompted their long awaited actions.
As the ADXS product funnel and focus has narrowed to NEO and HOT it seems increasingly likely AMGN will be the partner or owner determining our fate. I’m fine with that outcome.
G.B.
We don’t fully know how AXAL will compete head to head with Keytruda medically. We do have reasons to believe AXAL will compete favorably from a safety and treatment cost standpoint. These factors have proven to matter, in the EU at least, and will be critical in other less developed areas of the world.
Either purveyors of PD-1 and PD-L1 solutions will need to ratchet down treatment cost metrics or find their products operating beyond the financial reach of a large portion of the eligible patient population.
The windows of opportunity for ADXS are narrowing, but they still have meaningful advantages if they can get an Lm solution approved and in production.
G.B.
Interesting question fb... I assumed DO just negotiated licensing rights with AMGN to NEO. I don’t think he would have given up the IP rights.
G.B.
Hard to imagine AMGN would let their junior partner, who controls the NEO IP, stumble or expire financially on the threshold of important proof of concept efforts no matter what the terms were originally.
G.B.
Retrenchment...
“The reduction of costs or spending in response to economic difficulty.”
Reality has been faced at long last in Princeton, NJ. All the eggs are now in the HOT/NEO basket.
Shelving promising products, for now, isn’t necessarily tragic if they can hit just one home run that brings in a boatload of cash.
Another big “if”.
G.B.
High profile egotistical doctors and megalomaniacal lawyers who fancy themselves as wheeler dealers are a toxic mix. Not one grounded business executive in their midst to slap them silly when they start acting out.
Dan’s exit has all the hallmarks of a quick act of passion, anger and impulse. As suggested, very little thought was given to the aftermath of his firing or the leadership void it created. Since they had attached 5% of the companies treasure to his tenure, a calculating BOD would have worked him out over time while creating conditions that made him eager to go without backing up a Brinks truck to the loading dock. It’s page 87 in the, “How to gracefully and effectively exit your CEO”, handbook.
I doubt this BOD knows crap about succession planning as they’ve so clearly proven. The big institutions obviously love them and will tolerate their ineptness because they are wonderfully pliable.
G.B.
Agree the I&A conferences and the information shared hasn’t been well received by the market but... It was the one opportunity each year for a small die hard investor like me to travel half way across the country to corner Dan O’Conner and ask him directly why the conditional approval for AT-014 was taking so damn long. I was also able to engage Dr Petit, Dr. Paterson, Nicolle, Lombardo and various analyst in pointed questions about the company.
It concerns me they appear to be skirting this important interaction opportunity with investors. If they’re delaying the event this year for a valid reason, then do us the professional courtesy of saying that.
G.B.
Here’s the date and outline information from last years event. If they’re planning to host a similar event in June ‘18 they’ll need to start communicating details very quickly. If they elect to gloss over or skip the “annual” event that brings ADXS leadership in direct contact with analyst and investors, that sends a message too. At a minimum communicate if it’s on, being delayed or not happening this year.
DESCRIPTION
Advaxis will host its annual Investor & Analyst Day on Monday, June 12, at 1:00 PM in New York, NY. The event will feature a reception after the presentations at 4:00 PM. At this year’s Investor & Analyst Day, Advaxis will focus on “Patients, Partnerships and Progress” with presentations centering around the following areas:
Clinical Trial Update with Case Study Highlights
Plans for Data Dissemination and Timelines
Update on Advaxis’ Corporate Collaborations
Research Update on the NEO and HOT Programs
Progress Towards Regulatory Submission and Commercial Readiness
DATE AND TIME
Mon, June 12, 2017
1:00 PM – 5:00 PM EDT
Add to Calendar
LOCATION
Offices of Reed Smith
599 Lexington Avenue
22nd Floor
New York, NY 1
Long Investors delude themselves in thinking circumstances can still occur where short investors are crushed. High unlikely it can occur under current SEC rules.
Instead what we’ve been witness to is a well orchestrated long squeeze. An artificial market cap run up to roughly $1.1 billion dollars followed by the methodical transfer of created wealth to well organized short interests.
So not only are those 6.5M shares missing so are major portions of the artificially created value from the 2015 inflated market cap.
If a transaction like this doesn’t create a “woke” SEC, what’s it take?
G.B.
Interesting hold datapoints ub...
As we mull the possibility of a crippling FDA hold for AZN across all Imfinzi trials and approved products I’d suggest we first read the big sign posted in the FDA barnyard.
“All animals are equal, but some animals are more equal than others”
Apologies to G. Orwell.
G.B.
I’m concerned AZN holds the key to getting the hold lifted leaving ADXS with little leverage. I realize there’s a lot of “ifs” here but if the relationship between ADXS and AZN had soured, as was suggested as early as last June, AZN may simply not give a damn about the hold or the need to help get it lifted. They are running combo trials with scores of other small beauty pageant partners.
Leaving ADXS twisting in the wind, particularly if ADXS was building a stronger relationship with say, MRK, could be viewed as “screw you” justice by AZN.
Does anyone here honestly think these monster BP’s aren’t first class jerks and opportunistic bullies who expect these small cannon fodder biotech’s to kiss their rings, curry favor and get punished if they don’t.
G.B.
The FDA often expects some change or modification to the trial protocol to mitigate or eliminate the perceived
problem that caused the hold.
In this case, were I ADXS leadership, I’d make this concession to the FDA...
“We’re dumping our toxic partner AZN and stopping the trial involved”. “The trial is terminated and there’s no further risk to patients from Imfinzi, which you, the FDA previously approved for other medical treatments”.
The HOLD for a small biotech, trading at $1.80, matters greatly, to the small biotech. AZN could well be slow walking any requested data they’re responsible to provide because this trial with ADXS is a very low priority for them.
G.B.
As bourbon suggests the market hasn’t always reacted well to past I&A Days. Last year did include some interesting updates about AXAL data resorts based on biomarkers from Dr. Petit and Dr Masons 80 dog HER2 trial but also introduced whispers about a falling out with AZN as any mention of that relationship was conspicuously absent. There was also hallway discovery about the kerfuffle with PETX over wet or freeze dried application of AT-014. Revealed as one more reason to slow down the conditional approval application process.
The juice may still be worth the squeeze since you can back Noelle, Petit, or maybe even Berlin into a corner and ask them anything on your mind. There were institutional biotech short specialist lurking about if you want to actually observe the slime trail they leave every where they go.
Nice word play turning “annual” into “anal” raja... took me a minute to get it.
G.B.
I&A Day last year... “Annual Investor & Analyst Day, scheduled for Monday, June 12, 2017 at 1:00 p.m., will be webcast live.”
Assuming “annual” actually infers a recurring event, you’d assume the next I&A Day should be announced soon. Last years June meeting in NY provided unfettered 1-1 access to all ADXS leadership at the reception following the scheduled presentations. Dr. Paterson was also there as were various trial researchers, analyst and some long and short institutional investors.
Well worth the investment if you want direct interaction with ADXS leaders and others pulling the strings. Assuming annual means annual this year.
G.B.
blue... I agree 100% with your assessment of the current hold and the culpability of AZN, the fact their approved product has an established record of killing people, and their lack of interests to help ADXS in getting the hold lifted. Patients, who were benefitting and are now impacted negatively by the hold, are just collateral damage for the FDA.
Inexcusable and tragic.
G.B.
Aratana Therapeutics Appoints Craig Barbarosh and Lowell Robinson to its Board of Directors in Cooperation Agreement with Engaged Capital.
It does happen...
G.B.
Good find... Dr Mason announced this initiative and the grant from Morris Animal Foundation at the ADXS investors Conference last June. She also indicated they are hoping this expanded study will ultimately support treatment of osteosarcoma in children. Interesting it’s a modified formulary from the construct licensed to PETX. Probably how Dr. Mason is avoiding stepping on the license agreement with Aratana.
This initiative has received zero references from ADXS since they’ve de-emphasized HER2.
G.B.
I missed the direct connection Sidransky has to K. Berlin. Per Sidransky’s Morningstar biography he serves on the Board of Rosetta Genomics. He also had past links to ImClone. His medical resume and links to a number of company BOD’s are impressive.
He’s also 57 and likely not going anywhere soon unless he falls out of favor with a majority of the big Investment Funds who still hold large positions or gets run over by a bicycle messenger crossing the street in NY. We small retailers have strong opinions about his and the rest of the ADXS BOD performance, but not the numbers to effect changes.
From someone with a 40+ year business career, the preponderance of medical professionals (3) and attorneys (2), now (3) if you count Berlin, who make up the ADXS board has proven to be a serious blind spot in both company operation and governance. The long standing lack of fiduciary focus and conservation that must occur in a small biotech, to remain a going concern, is hard to comprehend, but understandable given the BOD makeup.
Attracting a veteran CEO of a Fortune 500 company for board service to keep the rest honest or from being snookered would have been absolutely invaluable. Someone who has lived the reality of budget management, ironclad principles of merit based compensation and incentive “pay for performance” bonuses tied to accomplishing key company goals.
That expertise would have likely avoided the O’Conner compensation heist as well as the recognition given a host of short sighted deals where valuable company assets were squandered or given away.
An admittedly bias, benefit of hindsight, view from an old business manager.
G.B.
If the company’s standing, as of today, is reflective of a management team who has pulled all the right levers for the past several years, WOW. How bad would things have been if they had been incompetent, inept and focused primarily on self interests and personal gain? We’d all have ownership in a smoking crater.
This company may well have science so good it stumbles its way into the immunotherapy promise land, but if so, it will only be because it somehow survived a recurring string of mediocre leadership. An honest appraisal of the collective record of company transactions and execution over time reveals a train wreck.
G.B.
“you have to assume that management knows more than we do...”
Sure hope so gajj. From an outsiders perspective they’re in a race with the financial clock as resources in the ADXS treasury are inexorably drawn down. Another dilution at levels lower than the last will be pretty tough to swallow and only buy a relatively small runway extension.
The fact everything appears to be business as usual with current staffing levels and continued hiring sure signals ADXS leadership doesn’t appear to have a worry in the world.
The company is overdue for an upside, slam dunk, zero ambiguity happy surprise... If there is one in the pipeline.
G.B.
Hovacre - Piggybacking on Traderbx and the host of queries about the just released abstract.
Is it simply counter-intuitive for companies like ADXS to provide English language subtext or context on data releases for consumption and understanding of mere mortals? I get the information primarily targets the medical research community but the importance of conveying understandable progress to non-medical research types would seem a given. Smart people on this MB, who follow the company closely, are left to debate if the news is good, ok or mediocre.
Perhaps it’s just further confirmation of ADXS tone deafness but if there’s a pony hiding under the data, ADXS should be touting it in simple terms the investing public can understand.
Thanks for your recurring efforts to decode company movements.
G.B.
Great background research on Edelman tpines.
“1,000 Share Trade at 7:02pm”
Wouldn't be the first nimrod to hit the “market” offer sell button accidentally. Other motives are not that obvious unless some short was just going for the big after hours drop optics. A dumb and meaningless gesture if that’s the case.
The big institutional adds are very encouraging.
G.B.
Extortion and or racketeering and it’s not like it’s being carried out under the cloak of darkness. Well executed in broad daylight over months and years. The discipline and sophistication are impressive. Appears to be foolproof with minimal risk of an official reaction.
If the SEC or DOJ ever woke to the activities occurring under their noses in the biotech and other sectors the penalties are on the books and well defined:
“Criminal penalties for racketeering include up to 20 years in prison, or life in prison, if the underlying crime supports that sentence. Fines for racketeering may be double the amount the defendant obtained through his or her crimes”
G.B.
I had similar impressions about yesterday mp... A strong reminder PR followed by 1.1 million shares traded which is 3X or 4X recent volume. Would seem to portend more news is coming, perhaps directly related to one or more of the topics highlighted in the PR. News about finding a home for HER2 would also be welcome.
I took a modest position in warrants fairly late for .70 and fled at .35. I’m certainly pulling for all those folks on the MB who have large holdings in warrants.
G.B.
ADXS has significant advantages in cost of goods and product pricing, if it’s ever recognized. Another big competitive edge the company should highlight in view of downward pressure on drug pricing.
If proven safe and effective the FDA should be doing all they can to promote alternatives like ADXS to toxic and expensive PD-1 and PD-L1 vendors.
G.B.
For those who love reading FDA Hold gobbledygook...
Since we’re nearing the two month mark it would appear time elapsed while ADXS and perhaps AZN initially responded to the hold, including any changes to ameliorate patient risk, and then 30 days for the FDA to react. Assuming this hasn’t morphed into a back and forth pissing contest with the FDA, we could be close on seeing the hold lifted.
Warning - Official FDA lingo follows...
• The regulations under 21 CFR 312.42 describe the grounds for imposing a clinical hold, as well as the requirements pertaining to the imposition and removal of a clinical hold order.
• The authority to impose, lift, and retain clinical holds on INDs has been delegated to division directors or acting division directors. This authority will not be further down delegated.
• For complete responses to clinical holds (responses that address all the deficiencies identified in the clinical hold letter), FDA has 30 calendar days to respond in writing. FDA’s response will either remove the hold or maintain the hold, and will provide the reason for such a determination (21 CFR 312.42(e)).
• A trial may resume only after the sponsor has been notified by FDA that the trial may proceed. Resumption of the trial will be authorized by FDA when the sponsor corrects the deficiencies identified by FDA when the hold was imposed or otherwise satisfies FDA that the investigation(s) is safe to proceed. FDA’s determinations are as follows:
- The information provided in the submission does not resolve all of the deficiencies identified in the clinical hold letter or new deficiencies are identified in the complete response and the trials under the IND may not proceed (hold is continued); or
- Trials under the IND are allowed to proceed with specific restrictions (i.e., full hold is lifted, partial hold is imposed); or
- All trials under the IND are allowed to proceed (hold is lifted)
G.B.
It was reported Noelle was seeking permission to IR the major buyers of the offering who she indicated were notable in medical funding. Didn’t happen. Also if greenmail, this blatant, took place, where are those lions of a fair and honest market, the SEC.
No response necessary, it was a rhetorical question.
G.B.