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Alan Robert Ross
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I started investing while getting my Ph.D. at McGill University. My research was on behavioral correlates of neurological control of cardiovascular function. After 25 years as a Professor, I quit to do something more exciting and more difficult: live off of my investments. For quite some time, I... More
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  • Why The FDA Would Be Foolish Not To Award PV-10 Breakthrough Therapy Designation  30 comments
    May 22, 2014 8:47 PM | about stocks: PVCT

    EXECUTIVE SUMMARY

    I think it is very likely that FDA approves Breakthrough Therapy Designation (BTD) for PV-10 in some indication of melanoma... but you need to why I come to this conclusion so that you can decide for yourself.

    UNDERLYING DATA

    But my guess, and it is only what I'd call an educated guess... can't be based upon a comprehensive study of past awards and rejections (as I'd like) because we don't have all that data in the public domain. We don't know what materials were supplied to the FDA by each sponsor, so we can't compare that to what Provectus supplied. We don't even know most of the drugs that had applications filed because most companies are too afraid to announce an application for BTD.

    We just don't have those details, so the decision is more difficult.

    We do have a recent case of a BTD approval, for Clovis, a few days ago. Clovis had a slightly smaller number of appropriately treated patient than Provectus "all tumors treated" group. Clovis had good results, but not as good as PV-10, results... and it was granted BTD. The Clovis drug that got BTD approval is not very toxic as cancer drugs go, but it has more side-effects and more serious side-effects than PV-10.

    The Clovis decision supports my view that the FDA will approve BTD for melanoma for PV-10, but my reasoning doesn't rely on the Clovis example.

    I will explain the rest of the reasoning that requires I make that decision, but I am going to do so, only after I make the point that, giving you this information, gives me no benefit, and it exposes me to be wrong... something analysts and pundits prefer not to do, as a general rule. I could just wait until after the decision and say, I told you so, even if I didn't.

    Since I am more than willing to admit than I am not infallible, I therefore prefer to explain my reasons to you and ask YOU to consider my reasons and reasoning as more important than my "guesstimate".

    In other words I WANT YOU TO CONSIDER THE EVIDENCE AND MAKE YOUR OWN DECISION.

    WHY THE FDA SHOULD GRANT BTD To PV-10 for MELANOMA

    To get BTD a drug is supposed to be

    1. for a life-threatening condition and

    2. more effective than the existing treatment.

    Melanoma is deadly and the data indicate that PV-10 works better than the competition... as proved by the patients in the Phase II trials. These people, on average, failed a median of 6 other treatments before they got treated by PV-10. And PV-10 worked (had an observable tumor response) for 71% of them.

    In the recent work by the Moffitt Cancer Center (to be fully presented at ASCO in about 10 days) 50% of the patients, also people who were not helped by a bunch of other treatments, had a COMPLETE RESPONSE... meaning their TUMORS actually DISAPPEARED. And there were very sick people, with terminal cases of melanoma.

    So we know PV-10 works for melanoma.

    It works better than currently available drugs.

    And melanoma is a serious condition, killing about 10,000 Americans each year.

    The criteria for the award of BTD are satisfied.

    THE KICKER: SAFETY

    We also know that PV-10 has no significant systemic side effects.

    PV-10 will not kill a patient, even if the person is old and weak and has a compromised immune system. PV-10 doesn't make patients weak and nauseous, make their hair fall out, make them pass out, interfere with their ability to keep food down, or ruin their blood count, or damage their liver or kidneys, like some other cancer treatments.

    It is also likely to cost $30,000 per patient or less to treat melanoma, compared to competitor Yervoy, which costs $90,000.

    The safety of PV-10 has been established by almost 100 years of being used in people's eyes or livers as a diagnostic aid.

    The drug safety issue with PV-10 makes approving PV-10 a no-risk, no-brainer decision for the FDA. If the FDA BTD Committee believes that more data needs to be collected, the FDA would know, in advance, that NO PATIENTS WOULD DIE SOONER because they were treated with PV-10.

    First, because the drug is safe.

    Second because scientists at the Moffitt Cancer Center have recently demonstrated that melanoma cells are effectively gone within 7 to 14 days after getting a shot of PV-10 into the tumor... in patients who had tried many other treatments; treatments that did not work.

    The FDA knows (unlike some investors) that approval of BTD is not the same thing as approval of an NDA. It does not automatically allow everyone to be treated with PV-10 indiscriminately. Approve of BTD status for PV-10 just speeds PV-10's progress towards a NDA filing with the FDA for final approval.

    Therefore, the only logical action on the part of the FDA, as I see it, is to approve BTD for PV-10. If the FDA BTD Committee thinks it would be smart to collect more data, they can have Provectus do that, before or after NDA submission. Provectus, to get approval in Europe, Australia, China, etc. is going to run at least a short trial in those countries, anyway. It is not a big deal, nor expensive, given that treated tumors shrink and can disappear in less than 1 month.

    THE DYNAMICS OF DECISION MAKING MAKE FDA PRONE TO APPROVE

    Decision makers, like an FDA Committee, dislike making decisions where a false positive reflects badly on the decision-makers, for example where they may lose their job or be demoted for being wrong. An example of a false-positive decision in the current context is when the FDA approves a drug that then kills people instead of helping them.

    In the situation I am writing about, approving PV-10, a false positive decision kills nobody and only postpones other treatment for a week or two.

    Saying "yes" to BTD for PV-10 in melanoma is probably the least risky decision the FDA BTD Committee can make all year. And if PV-10 fulfills its promise to make all solid tumors shrink and/or disappear, the FDA people who were instrumental is speeding this drug to market for the first of many indications will save thousands, actually millions, of lives by their action.

    As yourself what action would you take if you were on the FDA Committee and had this opportunity to help so many cancer sufferers and their families, with no significant risk attached.

    Would you reject it, slowing its progress?

    You decide...because the FDA is apparently about to do so. They will transmit their decision to Provectus any day.

    Disclosure: I am long PVCT.

    Additional disclosure: I have added to my position during the buying opportunity, this week.

    Themes: FDA, BTD Stocks: PVCT
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Comments (30)
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  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    Very nice Alan. Thanks for getting your thoughts on SA.
    22 May, 08:59 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Thanks Nick.
    23 May, 12:28 AM Reply Like
  • pensaman
    , contributor
    Comments (210) | Send Message
     
    well done Alan Ross...I agree. Indian women have used Rose Bengal for ages.. in a different format. It has not killed any because of it... LOL
    time to watch again
    http://bit.ly/1iblCQp
    23 May, 11:05 AM Reply Like
  • Mark Sams
    , contributor
    Comments (8) | Send Message
     
    Excellent article.
    22 May, 09:08 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Glad you liked it Mark.
    23 May, 12:29 AM Reply Like
  • MichaelJ8
    , contributor
    Comments (601) | Send Message
     
    thanks again TI.. or ARR now..

     

    If no BTD, then I will triple my position after the onslaught.

     

    If BTD followed by subsequent buyout... whatever... I'll go buy a house.

     

    If BTD bridging study required no buyout but partnership... I'll just slowly accumulate more until after NDA approval. Then I go buy a house and a car.

     

    In all situations... I win. Loving this.
    22 May, 10:26 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » You are welcome.
    I hope it is a large and very comfortable home, Michael.
    23 May, 12:28 AM Reply Like
  • MacCBOE
    , contributor
    Comments (32) | Send Message
     
    Dr. Ross, thank you for being a voice of reason in the wilderness. There has been so much rumour and innuendo about PVCT and the possible BTD by the FDA "any day now".

     

    Many shorts have used this as an opportunity to stir up the waters and get people to unload their positions, and then we who have done out DD must witness people with the unmitigated gaul to write libelous pieces about Provectus' researcher, Dr. Argawala and his supposed history of “drug trial failure” - he is a researcher administering drugs. He has no hand in whether the drug fails or not. This insinuates Dr. Argawala leads to bad drugs.

     

    All that being said, I mainly want to salute you for (to borrow from Wm. F. Buckley, Jr.'s famous statement), "to stand athwart history, yelling Stop. . . to these many naysayers with nothing more substantial to their opinions than the fact that they are SHORT PVCT stock and wish like mad for the stock to go down in flames.

     

    Again, thank you sir - for doing substantial due diligence and crafting that work into a easy to understand piece of work here on Seeking Alpha!
    22 May, 11:55 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Thanks for the kind words.
    I can't stand by while shareholders are figuratively mugged by slime who conspire and act to manipulate markets.

     

    Knowledge is power, but you have to have self-confidence and not be in over your head to resist being panicked by these propagandists using the Nazi Big Lie technique to undermine the facts.
    23 May, 12:27 AM Reply Like
  • jkrywyn_john
    , contributor
    Comments (24) | Send Message
     
    Very good and concise. I would point people to this article from ecancer.org which discusses some data to be presented at ASCO (American Society of Clinical Oncology) June 2014

     

    http://bit.ly/RVfK7r

     

    What’s really powerful about these results is that patients responded even after being refractory to the latest drugs including ipilimumab, anti PD-1 and/or vemurafenib,” said Wachter, adding it was unprecedented for a small molecule ablative agent to have this kind of immune system activity detectable in the peripheral blood of patients.
    22 May, 11:55 PM Reply Like
  • Fla_banker
    , contributor
    Comments (3) | Send Message
     
    MichaelJ8,

     

    You forgot to carry through your first assumption to conclusion. No BTD, triple your position and company abandons drug and fails. You never retire and will be found looking through a microscope when your 89....and your a smart guy who can not say that its at least a possibility.
    I am rooting for you and PVCT. But I am just saying this is not investing, this is gambling so triple down until the money is gone like a lot folks in Vegas.
    23 May, 12:10 AM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Gambling? Isn't that trading the stock, for a short period without due diligence, Fla? It seems Michael is in for the long haul, not for a trade.

     

    In the unlikely even the FDA act illogically and doesn't approve the BTD, Phase III trials will happen, with treatment lasting a couple of weeks and monitoring perhaps a couple of months. BTD is just a speeding up of progress. It is not a definitive acceptance or rejection of the drug by the FDA....

     

    And of course there is not a shred of evidence that PVCT will abandon PV-10. In fact Provectus is currently running a PV-10 trial for liver cancer, right now. So why do you even suggest it?

     

    So, given that you seem to be against gambling (and I infer therefore that you are a serious investor who does his sue diligence), perhaps you can tell us about the experimental results reported about the latest Moffitt research on PV-10. I think those results just made PV-10 and Provectus worth much more.

     

    Don't you agree?
    23 May, 12:42 AM Reply Like
  • MacCBOE
    , contributor
    Comments (32) | Send Message
     
    Well, I certainly agree - that the Moffitt research on PV-10 make the drug AND Provectus that much more valuable.

     

    And I'd just like to ask Fla Banker man "what's with the anger?" Are u bitter about some investment experience that you decided to take it out on Dr. Ross here, after a well-reasoned approach to his Due Diligence? Or are you perhaps BITTER that someone has come up with a cogent and evidential-based piece that does not quite mesh with the "sink to zero" wish that YOUR (apparent gambling) has taken you in PVCT, i.e. I believe you are most likely short the stock, and the piece published "anonymously" yesterday by the author who claimed "(Provectus) appears to have failed their Breakthrough Therapy Designation..." - which was quickly refuted by the company - better plays into your hand than Dr. Ross's piece.

     

    Mr. Banker, allow me to suggest that although I trained as a pharmacist, even my without my training I can easily see that Dr. Ross' words as well as his due diligence outscore the basher-piece yesterday from a factual basis.

     

    I suggest you either go back to the drawing board and recheck your facts, or just find a stock with more downside potential to borrow and sell short, say a General Motors or something. After all, what is there to be gained shorting a stock on the hard-to-borrow list of nearly every broker and also has a mere $2 of range to benefit for a short sale?

     

    Thank you,

     

    MacCBOE
    23 May, 01:49 AM Reply Like
  • ggrail
    , contributor
    Comments (18) | Send Message
     
    Standing up for what you believe in while the naysayers attempt to stampede the herd in another direction is laudable in this case. That you, Dr. Ross, and you MacCBOE, can do so without lowering yourself to speaking for others without their permission is also refreshing.

     

    The anonymous shorts trying to negatively influence others to their positions by using bullying and largely infantile scare tactics seem somewhat akin to those on the political landscape that attempt to shout down their opposition relying more on volume than facts.

     

    In the negative world of the short siders that attempt to tear things down through Sturm und Drang rather than reason, it is never that one set of facts are correct or incorrect, but how many converts you make. A sad commentary on the times and on those that attempt to use these tactics to gain an edge.

     

    Yeah, PVCT is small. Yeah, they might not be managed that well, nor slick. They may operate out of a barn or a garage and their employees might be over paid. But if they are on to something with their treatment and it works, the benefits to both society and the individual's this cancer touches would be immeasurable.
    23 May, 08:41 AM Reply Like
  • strinque
    , contributor
    Comment (1) | Send Message
     
    Its nice to see an article that actually does not try to distort the facts Alan... Thanks!
    23 May, 09:08 AM Reply Like
  • tonykarmen
    , contributor
    Comments (13) | Send Message
     
    tha screwballs that demonised provectus earlier this week must be held for trial ,they caused a lottttt of investors that had faith in pv10 including me 8 years ,not only for money but for HOPE OF CURING PEOPLE OF THIS HORRIBLE DISEASE INCLUDING FRIENDS THAT HAVE PASSED ON THE ATTY OR FED NEED TO INVESTIGATE THESE MANIPULATERS
    23 May, 11:07 AM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » I heard that FINRA already opened an investigation into market manipulation and that there may be another one by a Federal Agency. We shall see. These things tend to take time.
    23 May, 01:11 PM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    Looks like the FDA is foolish. Bummer. I'm still in it for the long haul though.
    23 May, 03:20 PM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    kretikos, if anyone invested money they didn't have then shame on them. Your comment is moronic.
    24 May, 09:12 AM Reply Like
  • mark woods
    , contributor
    Comments (154) | Send Message
     
    kretikos

     

    How does "a cigar chomping, dinner buying, back slapping, dirty joke spouting, sports ticket procuring salesman can make any company profitable"?

     

    Seriously.
    24 May, 09:54 AM Reply Like
  • kretikos
    , contributor
    Comments (42) | Send Message
     
    People were referencing this article from Mr. PHD as gospel even after the company had received but sat on its rejection letter.

     

    A cigar chomping salesman creates a sense of confidence, goodwill and optimism by words and deeds even when he has no credible insight into the product. I got out of this by the skin of my teeth, but feel free to stay on the laughing gas cause I suspect it will really hurt when it wears off.
    24 May, 10:19 AM Reply Like
  • mark woods
    , contributor
    Comments (154) | Send Message
     
    kretikos

     

    Keep it real.

     

    You say people were referencing this article as gospel.

     

    People.
    Not Alan.

     

    Alan said..

     

    "Since I am more than willing to admit than I am not infallible, I therefore prefer to explain my reasons to you and ask YOU to consider my reasons and reasoning as more important than my "guesstimate".

     

    In other words I WANT YOU TO CONSIDER THE EVIDENCE AND MAKE YOUR OWN DECISION."

     

    That's what Alan said. That is not pompous or arrogant or any other other behavior that is worthy of the label BULLSHIT.

     

    Your characterization of people in business as cigar this and sports ticket that is cartoonish and unworthy of you.

     

    There are people who deserve your wrath, and mine. They are not usually the ones who are the most visible, however. I do not know Alan but I have carefully read and checked his reporting. I believe he is sincere about his evaluation.
    .
    24 May, 10:34 AM Reply Like
  • kretikos
    , contributor
    Comments (42) | Send Message
     
    Ok goodbye leave you with this from Yahoo message board:

     

    I have every penny in it, I'm a believer!!! So much so, that I have my kids university account put in it. And I'm leveraged to the hilt, buying more on margin when it went to $3.40. Margin call is coming at some point and I might not be able to pay my mortgage. If I lose my house, Ill probably end up getting a divorce. I'm very very scared!!!
    24 May, 11:30 AM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    And that proves where you belong...on yahoo.
    24 May, 12:03 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » The rejection of the application for Breakthrough Therapy (BTD) designation for PV-10 is tragic for the people suffering from cancer that will die waiting longer for a drug that works well without nasty side effects. And it is certainly negative for those of us with large investments in Provectus, although it is likely only a postponement of our profit.

     

    The FDA acknowledged that PV-10 worked and that it reduced or eliminated from 1 to 10 melanoma lesions per patient. They said the drug worked, people.

     

    They also said they were not granting BTD because eliminating tumors is not the kind of data they think relevant for “locally advanced cutaneous melanoma.”

     

    Seems relevant to me and I bet it seems relevant to most of you, but it was not related to the "clinical benefit" of the drug, as defined by the FDA. I think the FDA was wrong, but I am not an MD and I don't work for the FDA. It is up to them, not to me, obviously.

     

    I based my expectations on the assumption that the FDA would be overjoyed to see a 71% Observed Tumor Response rate. That is why I was mistaken and I regret if what I considered my logical assumptions misled you. As I said in my article, I know I am not infallible and that's why I explain my reasoning and not just provide people with a judgment.
    Hopefully with time, Provectus or its successor will provide PV-10 to cancer victims.
    24 May, 08:13 PM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    After listening to the CC just now I am fully satisfied in the direction the company is taking and excited for the new direction, which will be announced after the ASCO in early June.

     

    Alan, your work along with Dom's, is what most of us also look forward to. In the end we are all responsible for our own decisions. I'll take the hit now believing myself that PVCT is STILL a solid investment.
    24 May, 09:16 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Thanks for the kind words, Nick.
    I never miss a post by Dominic!
    Nick the company promised some sort of presentation at ASCO outlining their plans and I think there will be more Moffitt data presented... probably something that was completed AFTER the Abstract was submitted to ASCO.
    25 May, 12:56 AM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    All the more reason to still be excited Alan:) Thanks again!
    25 May, 02:59 PM Reply Like
  • jkrywyn
    , contributor
    Comments (174) | Send Message
     
    The FDA was foolish, in my opinion. They are a data-driven robot, it seems. They would rather quantify how much a drug hurts a person and know the data – even how many patients die from treatment – as long as they know the data. They want a lot of quantifying rather than the safest drug available, it seems. Just look at these excerpts from the May 2014 update to FDA breakthrough guidance and you will see that Alan and everyone else would have thought logically that the FDA would approve PV 10 for breakthrough therapy. Especially given the fact that breakthrough therapy will usually require more studies to give them the data they need. It is not a new drug application and is not approval of a drug.

     

    The FDA could've given break their designation in order to work more regularly and more closely to advise Provectus while conducting more studies. Because breakthrough designation does not mean approval of the drug there was really feel risk given the outstanding data provided by Moffett and several other clinical hospitals about the drug

     

    Pg 15 (pg 11 on the document): "Other types of clinical data that also could be persuasive include single-arm studies comparing the new treatment with well-documented historical experience. Generally, FDA expects that such historically controlled data would be persuasive only if there is a large difference between the new treatment and historical experience. For example, where lung function decline is a major manifestation of a disease, single-arm study data showing that a new drug significantly increases lung function could be persuasive if there is no available therapy that increases lung function. Data demonstrating that a cancer drug substantially increases overall response rate compared with historical controls (e.g., historical response rate with available therapy), with consideration of duration of the response, also could be persuasive. Sponsors contemplating the use of historical controls should consult FDA’s ICH guidance for industry E10 Choice of Control Group and Related Issues in Clinical Trials for more-detailed discussions."

     

    Pg 16 (pg 12 on the document)
    "Substantial Improvement: The determination of whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the drug’s effect on a clinically significant endpoint (which could include duration of the effect) and the importance of the observed effect to the treatment of the serious condition or serious aspect of the condition. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

     

    Approaches to demonstrating substantial improvement include the following:

     

    • Direct comparison of the new drug to available therapy shows a much greater or more important response (e.g., complete responses where the control treatment generally results only in partial responses). Such a trial could be conducted in treatment-naïve patients or in those whose disease failed to respond to available therapies, either as a comparison with the failed therapy (if ethically acceptable) or as a no-treatment controlled study. "

     

    (what about the refractory patients who did not respond to available treatments but to pv-10? Did they have that data?

     

    "The new drug has a substantial and clinically meaningful effect on the underlying cause of the disease, in contrast to available therapies that treat only symptoms of the disease.”

     

    Um. Yes….pv-10

     

    • The new drug has an important safety advantage that relates to serious adverse reactions (e.g., those that may result in treatment interruption) compared with available therapies and has similar efficacy. "

     

    Um. Yes….

     

    "Clinically Significant Endpoint: For purposes of breakthrough therapy designation, FDA considers clinically significant endpoint generally to refer to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. It can also refer to findings that suggest an effect on IMM or serious symptoms, including

     

    Pg 17 (13 on document)

     

    • An effect on an established surrogate endpoint that typically would be used to support traditional approval “ (symptom control)

     

    "• An effect on an established surrogate endpoint that typically would be used to support traditional approval “

     

    Pg 18 (14)
    "In rare cases, a pharmacodynamic (PD) biomarker may be considered a clinically significant endpoint if it strongly suggests the potential for a clinically meaningful effect on the underlying disease. In such cases, a sponsor should provide evidence supporting the use of the PD biomarker. Such evidence should include, for example, (1) the extent of understanding of the disease pathophysiology, (2) whether the biomarker is on a causal pathway of the disease process, and (3) the time course of the drug’s effect on the biomarker (e.g., the biomarker can be measured earlier than a surrogate endpoint used for accelerated approval). In addition, strong evidence of the drug’s effect on the PD biomarker generally is expected. FDA is more likely to
    rely on a PD biomarker for breakthrough therapy designation in a disease setting in which there is no available therapy, if the evidence supports such use.”

     

    “As discussed previously, breakthrough therapy designation will usually mean that the effect of the drug will be large compared with available therapies.”

     

    http://1.usa.gov/1mFU4GC
    1 Jun, 01:12 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » That's a very comprehensive and well documented argument you have crafted.
    Bravo!

     

    We can see in the recent Ebola and PV-10 experience that FDA orthodoxy and pre-conceived notions may put saving lives and reducing suffering at a lower priority level than they should be.

     

    For all their requirements of understanding mode of action and requiring scientific proof, they apparently do not really understand the idea of risk versus reward. If not using an effective treatment means death, what benefit is there to withhold approval from a drug that they concede "works" and has a 100 year exemplary safety record in human use, like the basic ingredient in PV-10?
    In the case of withholding BTD approval for PV-10, the risk was not that people would be treated and not helped, losing money for no reason and possibly being deterred from seeking other treatment, because BTD is not approval.
    Nobody would have been put at risk by treatment with PV-10 if BTD status had been approved. PV-10 would still have had to be shown to be effective as well as being safe. Nothing would have been lost to speed development in hopes of saving lives that would be lost because of FDA dithering. 
    12 Aug, 02:06 PM Reply Like
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