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[Update 2016-02-23]In light of recent studies [American Journal of Clinical Pathology], it seems highly unlikely that Theranos has achieved any comprehensive technological breakthrough. Their reluctance to disclose technology and data (they are supposed to publish data in the next week or so) even after four months and with the negative publicity piling on seems to underscore the point that they probably had no statistically relevant studies of their own technology to begin with. A best-intentions conclusion is that their management suffered from an overestimation bias from limited observations on 'friends and family'.I expect whatever results get disclosed at the behest of Theranos at this point will suffer from self-selection, over-massaging and false equivalence, while still maintaining the obscurative descriptions of their technology. They will conclude that their technology shows as much variability as commercial clinical hematology analyzers and will not allow any independent third-party examinations. I expect that the FDA will have concerns with such results and I fully expect a guidance on the use of finger stick based metrology in POC/clinical diagnostics in the next one year frame.Thanks for noticing this Terrence!tldr: Compliance, marketing and regulations are red herrings in this discussion. The core issue is technology, and its novelty and efficacy.I personally have exceedingly limited and very specific experiences restricted to radiological device premarket qualification/501k to be able to answer this question directly.I receive FDA CDRH (Center for Devices and Radiological Health) bulletins that contain recall and 'lack of compliance' notifications and updates for many major device makers. There are usually 3 or four such notices every week. Some issues are more egregious than others, but there's usually no corresponding public outcry and companies don't go out of business following such notices.Regulatory hurdles are generally not spikes of death, where if you stumble on one, you die. Usually people figure out how to either clear or circumvent the hurdles sooner or later and go about business after that. 23&Me is an example (and so are Abbott, Stryker, GE health, Medtronic..).Violations of regulations is bad, but it is an ordinary fact of healthcare QC because of the many, complicated, moving pieces. Such regulations themselves are not 'rules set in stone', but a matter of continual public discourse and academic/economic/legislative thought on 'what makes sense today' (FDA advisory Committees). FDA does generally have a problem with you if you are a repeat offender and do not respond to guidance (for example, Syntex/IBT Labs/naproxen flap in 1976).That's why I think that there are some misinterpretations in some of the post-Oct 14th opinions and analyses we hear about Theranos. For example, 483 observations are intended as non-comprehensive external feedback to the company's management, and as records meant for FDA to track a company's progress towards compliance.They are not an official critique like gossip has made them out to be. Inspections may also be scheduled or unscheduled, and does not exactly reflect on any particular issue (unless there was a complaint; this data is yet undisclosed). I am pretty sure that Theranos employs plenty of FDA regulation consultants to advice them, so they know what they are doing. This is standard practice.The following links illustrate the regular process for inspections and observations. I won't quote specifically from these since they may be interpreted out of context.FDA Form 483 Frequently Asked Questions(FDA inspection scheduling) What should I expect during an inspection?SUBCHAPTER 5.2 - INSPECTION PROCEDURESSUBCHAPTER 5.2 - INSPECTION PROCEDURES (Refusal of entry)Investigator/Staff Guidance for FDA InspectionsTips on Preparing for an FDA Inspection(The guidance on 'refusal of entry' illustrates that not all inspections may be scheduled a priori. FDA is both authorized as well as invested in in flagrante delicto)Some more data on what FDA considers as official censure: FDA enforcement statistics FY 2014 [pdf].The table below shows 6 big categories that FDA considers censure events (FDA Compliance and Enforcement Information). This is what FDA does when it thinks you are doing something not good for the public or a violation.483 observations don't make it to this list. And note that a warning letter is the first step on the road to FDA hell. IIRC Theranos hasn't made it to this step yet.23andme did, and they are doing fine.This should indicate that (1) 483s are not official censure (2) inspections may happen scheduled or unscheduled. This provides some external corroboration for claims made by Dr. Becker.As I have mentioned elsewhere, there's only a singular issue that Theranos needs to come clean on - The accuracy, precision and applicability of their 'new or unique technology'. That's the only one that matters in the discussion.Otherwise we risk asking the company easy questions that make them look better than pre-Oct 14th.[That's precisely what happened during the WSJD Live/2015 conference.]They can tweak all their marketing claims (exactly what they did by changing their website; don't forget "the website is constantly being updated"), they can readjust all their claims on regulatory compliance, they can create new business models. IMIO we also waste time in discussing the nanotainer nonsense. It's a very basic technology, and will probably receive all kinds of clearance shortly. But again, that doesn't have anything to do with the actual technology that carries out the metrology.I mean, anything can be tweaked. Except for the technology and the actual science.HOW do they carry out ~200 tests on such a small volume of blood?HOW does their metrology maintain the accuracy and precision?WHAT mechanism in their system prevents contamination-during-collection issues?WHAT is the comparison between data obtained by a 3rd party agency operating their equipment and equipment from established diagnostics vendors?If comparison cannot be established, then the 3rd party agency should also provide statistical results showing usable correlations with disease predictions.We do not need the exact technology description. But we do need the general description of the physics they employ - if their IP has value then they should have already patented this.There is a lot of precedence for such technology disclosures. For example,Here's i-STAT corp's 1988 patent (Patent US5096669 - Disposable sensing device for real time fluid analysis),Here's one of the earlier 3rd party performance verifications of the i-STAT device (Erickson/iSTAT/1992 [pdf]),Here's another 3rd party report from 2002 after they had sold their 20,000'th device (Papadea/i-STAT/2002). This report compares istat with other commercial devices.(Note i-STAT was founded in the mid 80s, their first patent is from May 1, 1987; it took at least about 11 years, till about 1998, and countless peer-reviewed medical publications and studies before the devices started getting accepted in the early 2000s. They were acquired by Abbott in 2003 for ~400M)That's what we need to wait for; not FDA reports, not SEC filings, not shareholder letters. So Dr. Becker's views regarding IP protection are not exactly valid.Karen M. Becker, PhD | Precision AdvisorsDr. Becker appears to have a very accomplished profile, so I personally believe that she would not produce opinions that could damage her professional reputation. This is her line of expertise.She might of course use favorable language where there may have been a choice, but the media has also already used unfavorable interpretations where there was a choice.Disclaimer - I have no bone in this. I do not work for Theranos or "the industry incumbents" or any one involved in marketed healthcare. I work in RnD, in segments that none of these companies have an interest in. I am only tracking this topic for the education in how medical technology companies need to behave and the inevitable, cheap lulz and lessons arising from media+marketing getting things wrong. Also, don't like the idea that an entity can be publicly crucified without fair interpretation (neither do I like anyone being exalted without due verification, but that also happened). And speaking of lulz - Dynapy and 'PRICKS'.