Part 2
If you don't stand for something, you’ll fall for anything. This pretty much sums up Mannkind’s stand on the lawsuit. The shareholders can put this issue to rest now.
Mannkind posted a new 8-K
Item 8.01 Other Events.
As previously reported, on September 16, 2010, a former employee, John Arditi, filed a lawsuit in the Law Division of the Superior Court of New Jersey (Bergen County), against us and two of our officers. Pursuant to an existing arbitration agreement, Mr. Arditi had previously agreed to resolve claims relating to his employment through arbitration. On November 22, 2010, we confirmed that Mr. Arditi had filed a Notice of Voluntary Dismissal with the court on November 18, 2010, dismissing his lawsuit without prejudice. We did not make any payment or provide consideration of any kind to Mr. Arditi in connection with this dismissal. As of the date of this report, Mr. Arditi has not initiated arbitration.
-------------------------------------------------------------------------------------------------
Part 1 (posted few weeks back when lawsuit was first filed. )
These are trying times for the patient long term investors of Mannkind corp. The Arditi lawsuit is another one in the long list of issues impacting the stock price that is outside the control of Management.
They are a few things to consider before one decides to take any action.
a) The safety and efficacy of Afrezza are undisputed.
b) Mannkind has performed both internal and external investigation on this issue. The company says in the PR that no evidence of problem was found. If an evidence of problem was found, the company has to file a 8-K with SEC as per the regulations. So far, the company hasn’t filed any 8-K regarding this matter.
c) The FDA had conducted inspection of Russian trial sites and did not issue form 483.
d) All the data from Bulgarian and Russian sites were submitted to FDA. FDA hasn’t raised any issues in the CRL. FDA hasn’t asked Mannkind to perform any new trials. In fact, FDA approved Mannkind to perform pediatric studies for children ages 4 and above
d) Bulgaria was involved in only one Phase 2 trial named “MKC-TI-010”. In that trial 228 patients were enrolled. Out of 40 sites that were part of this trial, 8 were in Bulgaria. This trial was completed in October 2008 and FDA has signed off on it.
e) There is nothing in 50+ year’s of Alfred Mann’s public life to suggest improbity & impropriety. People leave a long paper trail. There is nothing to indicate that management had tried to cut costs. In fact, in one of the conference calls, Al Mann said, “I asked my team as to why we need to perform these elaborate trials?” Nevertheless, they went ahead and performed a large trials treating Afrezza as a new compound. Mannkind is doing superiority trials even though FDA hasn’t asked for it. All their actions indicate that if there were a genuine concern on the Russian/Bulgarian trial site, they could have easily dropped that data and performed new trials to augment it. Al Mann’s management team is even more cautious.
f) Matt Pfeffer (CFO) says that the “The FDA has been made aware of all the details and has so far expressed no concerns.“
g) The timing of the lawsuit is very suspect.
This is the time to go back and review the reasons for your buying the stock originally. If the original reasons haven’t changed, then there is no point in selling based on market rumor or baseless claims. My reasons for buying in the first place are
1) The potential of Afrezza
2) Al Mann’s track record of bringing successful products to the market.
Warren Buffett said, “it takes a life time to build a reputation and days to destroy it”. Al Mann’s reputation has been built over his life time.
Let us look at what FDA does when it inspects a site.
From the link:
IV. HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
Upon arrival at the clinical investigator study site, the FDA investigator will display his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) to the clinical investigator or appropriate study staff. FDA is authorized at reasonable times to access, inspect, and copy any required records related to the clinical investigation. See section 704 of the Federal Food, Drug, and Cosmetic Act (21 USC 374), 21 CFR 312.68, and 21 CFR 812.145.
During an inspection at the site of a clinical investigator, the FDA investigator typically verifies compliance with the regulations governing the use of investigational products and human subject protections at 21 CFR parts 50, 56, 312, and/or 812, by inspecting records and talking to individuals involved in the conduct of the study to ascertain:
• who performed various aspects of the protocol for the study (e.g., who verified inclusion and exclusion criteria, who obtained informed consent, who collected adverse event data);
•whether the IRB approved the protocol, informed consent form, and any amendments to the protocol prior to implementation;
•whether the clinical investigator and study staff adhered to the sponsor’s protocol and investigational plan and whether protocol deviations were documented and reported appropriately;
•whether informed consent documents were signed by the subject or the subjects’ legally-authorized representative prior to entry in the study (i.e., performance of any study-related procedures);
• whether authority to conduct aspects of the study was delegated, and if so, how the conduct of the study was supervised by the clinical investigator2;
• where specific aspects of the investigation were performed;
• how the study data were obtained and where the study data were recorded;
• accountability for the investigational product, including shipping records and disposition of unused investigational product;
•whether the clinical investigator disclosed information regarding his financial interests to the sponsor and/or interests of any subinvestigator(s), spouse(s) and dependent children3;
• the monitor’s communications with the clinical investigator;
• the monitor’s evaluations of the progress of the investigation; and
•corrective actions in response to previous FDA inspections, if any, and regulatory correspondence or sponsor and/or monitor correspondence.
When FDA considers whether to accept non-U.S., non-IND clinical studies in support of an IND, NDA, or BLA, an FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 312.120. Specifically, the inspection will evaluate whether the following criteria are met:
• The study is well-designed and well-conducted.
• The study is conducted in accordance with Good Clinical Practice (GCP), which is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.
• The study has been reviewed and approved (or provision of a favorable opinion) by an independent ethics committee (IEC) prior to study initiation, continuing review of an ongoing study by an IEC, and the freely given and documented informed consent of the subject (or the subject’s legally authorized representative if the subject is unable to provide consent) prior to any study-specific procedures.
Studies Involving Investigational Devices
FDA’s inspection of clinical investigators conducting foreign trials includes device trials in support of a premarket approval application (PMA) or a premarket notification (510(k)) submission.
For device studies conducted outside the U.S., FDA will accept research in support of a PMA, but which has not been conducted under an IDE, if certain conditions are met. An FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 814.15. Specifically, the inspection will evaluate whether the following criteria are met:
• the data are valid; and
• the studies are conducted in conformance with the "Declaration of Helsinki,"7 or the laws and regulations of the country in which the research is conducted, whichever affords greater protection to the human subjects.
FDA validates the authenticity and accuracy of data and confirms compliance during an inspection, which is performed under the circumstances listed above in section III. The FDA investigator may request documentation as to whether the study was conducted under the laws and regulations of the non-U.S. country and/or the Declaration of Helsinki, whichever accords greater protection to human subjects.
VI. WHAT HAPPENS AFTER AN INSPECTION?
At the end of an inspection, the FDA investigator conducts an exit interview with the clinical investigator or his/her representative. At this interview, the FDA investigator who conducted the inspection reviews and discusses the findings from the inspection and, if deficiencies were found, issues a written Form FDA 483 (Inspectional Observations; 483) to the clinical investigator or his/her representative. The 483 describes any inspectional observations that, in the opinion of the FDA investigator conducting the inspection, represent deviations from applicable statutes and regulations.
Some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection include:
•failure to follow the investigational plan and signed investigator statement/agreement (e.g., failure to conduct or supervise the study in accordance with the relevant, current protocol(s)). See 21 CFR 312.60 and 812.110(b).
•protocol deviations (e.g., failure to appropriately document and report any medically necessary protocol deviations). See 21 CFR 312.66 and 812.150(a)(4).
•inadequate recordkeeping. See 21 CFR 312.62 and 812.140(a).
•inadequate accountability for the investigational product. See 21 CFR 312.62(a) and 812.140(a)(2).
•inadequate subject protection, including informed consent issues. See 21 CFR part 50, 312.60, and 812.100.
Posts
