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Cleveland BioLabs, Inc. Message Board

cats44ever 19 posts  |  Last Activity: Sep 25, 2014 4:20 PM Member since: Aug 9, 2004
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  • Reply to

    AOLS gets "Red Light" from FDA

    by cats44ever Sep 24, 2014 8:54 PM
    cats44ever cats44ever Sep 25, 2014 4:20 PM Flag

    It's just odd that the other companies human safety studies have been stopped before they've even begun.....i mean they're just safety studies. Maybe there's been some odd side effect discovered in their primate trial.....and that's why the FDA blew the whistle. It does seem that the human part of the 'animal rule' process is the most trying.

    Sentiment: Buy

  • AOLS Human trials placed on clinical hold by FDA. God knows when they'll let them start. And not even a news release...... just tried to sneak it by in an SEC 8k filing & they'd gotten word of it 2 days ago.

  • I'm starting to feel that this is a definite possibility.....I thought it a touch odd, the amount of detail mentioned regarding approximate costs & personnel required to complete the filing back on the "Green Light" call. Even though it would only be a tiny drop in a drop in the bucket money-wise, there would be some real significance as far as the perception of government interest.

    Sentiment: Buy

  • cats44ever by cats44ever Sep 15, 2014 12:05 PM Flag

    Well it's been a year since SNGX announced with great fanfare that BARDA had chosen to fund their ARS drug and so far, with the initial payment they've received, they've done.........ah.....eh........errrrr.........nothing just yet. But!!!!.......they're thinking really hard about it!!

    Sentiment: Buy

  • Reply to

    Welcome Back Sabby

    by cats44ever Sep 8, 2014 7:24 AM
    cats44ever cats44ever Sep 8, 2014 12:21 PM Flag

    I'm totally on Biolabs side but i believe Sabby had every right to be angry & suspicious about the unusually strange & disastrous timing with their secondary & the BARDA announcement a week later. It's actually a very fair compromise for both Sabby & Biolabs. Sabby is giving up roughly 2 million of series B warrants which would have expired next July & CBLI is extending the 2 million longer term series A warrants by an additional 2 years & lowering the price as you said. If the stock somehow goes up to $2.50 by early next summer they'll lose out big time. That being said it's nice to know that now they believe in Biolab's innocence in the matter and this will make it so much easier for any money raising efforts going forward & i wouldn't be surprised to see them as the main player in the upcoming secondary

    Sentiment: Buy

  • cats44ever cats44ever Sep 8, 2014 8:46 AM Flag

    You're really barking up the wrong tree here. CBLI's recent problems have been all about the HUMAN trials and dose conversion ratio & getting acceptance from the FDA. That was THE issue and why BARDA rejected CBLI's white paper back in early 2013, CBLI seemed to have gotten exasperated with the immense amount of time it was taking between FDA meetings & mistakenly made assumptions that BARDA wasn't comfortable with. The conflict being over whether the FDA would except and approve of the dose conversion. This all finally agreed upon & resolved with the recent release of the FDA minutes. There has NEVER been any issue with the NHP trials, The FDA pretty much immediately accepted the results & never requested any additional efficacy data and now with the the NHP safety data complete, CBLI is DONE torturing those poor Macaque monkeys (!!). As far as publications, i remember seeing one that was linked in one of those Seeking Alpha articles a couple of years ago, i don't recall it now, maybe somebody else here can chip in......you can always call investor relations & they can give you the specifics as this seems to really concern you. I'm really not on these boards to convince anyone to buy anything or sell anything, but personally, i've had a horrible history with bulletin board & pink sheet stocks & if for whatever reason, CBLI decided to delist or move to the Bulletin Boards.......and BTW, for those that don't know, they're getting a 180 day extension to address the sub $1 Nasdaq pricing issue, i would have to sell it on principal. For this reason, i could never consider AOLS seriously. Even forgetting the fact that they have less employees than i have fingers on 1 hand, their office rent is less than my apartment rent & that for whatever reason, they decided to reprice 59 MILLION SHARES OF WARRANTS TO ONE PENNY (????!!!??) a year and a half ago. Re Soligenix, they really only got one of those "BARDA starter deals", that's only about $4-5 million/year

    Sentiment: Buy

  • cats44ever by cats44ever Sep 8, 2014 7:24 AM Flag

    have to admit, this ongoing issue was bothering me & great to see it resolved. One of the reasons the stock has been under so much pressure is that Sabby has been selling most of their position. I realize they did take a small part in the recent June secondary, and that seemed to suggest the relationship was not overtly hostile, but it's nice to see that they've dropped the $2M lawsuit, which i'm sure was a dark cloud that any future investor had to overlook. The agreed upon compensation seems more than reasonable for both sides and looking forward to Sabby supporting CBLI in the near future

    Sentiment: Buy

  • cats44ever cats44ever Sep 4, 2014 8:31 PM Flag

    In a slightly more serious tone, let me add that truly successful AOLS trial results (at least a little closer to the CBLI numbers......say 25/placebo to 60/compound or better) would have permanently crippled CBLI's chances with BARDA/DOD/HHS/etc. going forward. The survivability numbers in these final primate efficacy studies are ALL THERE IS to prove the drug does what it's needed to do. The mouse studies are really meaningless at this point. The tests for both companies are over, the results are in & CBLI's numbers are MUCH better, hands down, and this is something BARDA will obviously consider when it comes time, in the very near future, to deciding whether to exercise it's remaining OPTION with the balance of the AOLS contract. Quite possible that CBLI may eventually be taking AOLS's "lunch money" .

    Sentiment: Buy

  • Reply to

    Cash Needs

    by fpmiike Sep 4, 2014 2:54 PM
    cats44ever cats44ever Sep 4, 2014 3:43 PM Flag

    I was only thinking they need $12 million to make it through 2015 & hoping that they play "nice" & limit the raise until after the FDA filing. Wainwright & Wunderlich both on the CC so i have to think the secondary is Plan A & coming very soon. Before that i think we will definitely get some great 137 interim results (which could come in the next two weeks) & possibly 512 as well. Would be nice to get an additional pop from that......get close to $1 & then kick out the new shares at 75 cents, but at this point, if there was a smallish raise at 60 cents......it is what it is.

    Sentiment: Buy

  • cats44ever cats44ever Sep 4, 2014 2:56 PM Flag

    First of all, there's no mention of how many subject primates were involved in AOLS's study. That's a bit of a peculiar omission. Second, they mention that the drug was administered for 60 days (??!). How would that even be remotely possible in the field? Contrast that with CBLI's 6/2012 primate study results where only a SINGLE dose was given 25 hours after irradiation.

    Sentiment: Buy

  • Totally mind numbingly incredible numbers...........50% of the AOLS treated monkeys survived, compared to 25% in the control group!!! Compare these results to the confoundingly ineffectual CBLI study where ONLY 70% of the treated monkeys survived, compared to 27% in the control group. It doesn't take a rocket scientist or even a hairdresser to see that Cleveland Biolabs might as well pack it in in the ARS department!!!!

    Sentiment: Buy

  • Reply to

    FDA Minutes

    by cats44ever Aug 7, 2014 2:24 PM
    cats44ever cats44ever Aug 20, 2014 10:12 AM Flag

    Hey Fpmiike. At this point, there's no chance of the stock going over $1 for 10 days before the Naz deadline so they need to address that by announcing their request for a 180 day extension before anything else. Any kind of stock split right now would be a tactical error (see NEWL for stocks that insist on splitting to satisfy & where that got them vs PLUG as an example of a company that's handled it perfectly). They need to share with potential secondary investors the results of the FDA meeting-minutes first, then possibly announce wildly successful (hey....anything's possible) interim 137 results to brighten the picture. Quite likely we get the news of positive resolution to the EUA filing inquiry & the secondary the same day, the way they did two years ago when the stock was sold at $2 & the BARDA submission was made. I'd be happy with a smallish raise of about $6-8 million with the company hoping for an improving picture & stock price to capitalize on later. In the anything's possible world, maybe getting EUA filing approval somehow satisfies the unfulfilled portion of the prior-quite-likely-expired DOD deal and they decide to "re-up".

    Sentiment: Buy

  • Reply to

    FDA Minutes

    by cats44ever Aug 7, 2014 2:24 PM
    cats44ever cats44ever Aug 19, 2014 7:09 PM Flag

    I searched & found the article right after i saw your first post, CBLI is a common subject for the Buffalo newspapers for obvious reasons & did in fact see the date July 18th as the FDA meeting-day when i searched it this afternoon. Now that i'm reading your reply i checked again to make sure i'd found the correct article (i had) & it seems the piece has been revised & there are some changes to what you pasted here including the date which has now been changed to a "one day meeting in July". Reread it now & compare it to what you pasted on this board.

  • Reply to

    FDA Minutes

    by cats44ever Aug 7, 2014 2:24 PM
    cats44ever cats44ever Aug 19, 2014 11:40 AM Flag

    At least now we know the exact date of the meeting, 7/18.

  • has made the public & mainstream news agencies so much more aware of what Emergency Use Authorization is. Seems like the three drug companies vying for a medical solution are all going that route.

    Sentiment: Buy

  • cats44ever by cats44ever Aug 7, 2014 2:24 PM Flag

    I'm tired of defending this stock & the price is what it is because they're going to need to raise money before mid-October, and that sucks....., however.......anyone thinking of dozing off while waiting for the FDA retort will be in for a quick wake-up. Minutes are sent out 30 days after the meeting 99% of the time (for some reason this statistic was posted on one of the gov-sites). Assuming the meet took place July 14th - 22nd, that means the company will very shortly have the response....... within a week or 2, & depending on what it is & what strategy they intend to follow, we should be hearing what happened & what will happen before the end of August. Significant is Kogan's text statement that they were "Encouraged" regarding the FDA-meet, followed by his comment during the CC that they were "Very Pleased". All this smells of decent confidence as superlatives are not normally a European tendency. This means that this company has an excellent chance of being the VERY VERY FIRST(!!) biotech to have a radiation countermeasure approved (!!). Even Amgen's Neupogen isn't approved in this capacity.

    Sentiment: Buy

  • I've done a tiny bit of reading on Emergency Use Authorization & PAHPRA. It's all so new (started in 2013) & only a handful of submissions, mostly for Avian Flu but also for Anthrax & Ebola. Encouraged to see the British company Takmira trying to establish proof of it's compound vs Ebola with a quite small (28 patient....7 cohort) human safety trial as the CBLI human study group has been larger. Seems like the FDA would have little trouble with any conscience over premature EUA drug approval because the usage of any drug under these conditions has to wait until one of the other government bodies (HHS, DOD etc) declares an 'emergency'. Would appreciate anything anyone can add on this matter.........

    Sentiment: Buy

  • Reply to

    Date between FDA and CBLI

    by zgcorp Jul 5, 2014 10:16 AM
    cats44ever cats44ever Jul 21, 2014 12:54 PM Flag

    First off, the question you're asking is one we'd all love the answer to but....unless you work at CBLI or the med-imaging division of the FDA, there isn't an answer to your question to be found here. Company policy has always been to not disclose specific dates of meetings with any of the government agencies (HHS/FDA/DOD). That being said, let me summon all my Sherlock-Holmsish deductive powers & hazard a guess as answer to your question. Last months excellent post by 'Pinstripe' covering the annual meeting stated that the company chose to let us know that the FDA meeting would be in "Mid July"........so being that even the most optimistic interpretation of "Mid July" ends tomorrow & unless there's some really odd trading today/tomorrow, my feeling is it took place either very end of day 7/11 or beginning 7/14 as the volume early on 7/14 was somewhat peculiar. It went up a tiny bit & then down & i'm sure the optimists came away with "What a great presentation" & the nay-sayers followed with "All they had was Lipton iced tea as refreshment & the one guy kept yawning & looking at his watch". As far as what to expect after...... The real horseshoe contest comes when the FDA release minutes/transcripts 30 days post.

    Sentiment: Buy

  • cats44ever by cats44ever Jul 11, 2014 12:46 PM Flag

    Lebron James just now signed with the Cleveland Cavaliers. Add that to the Cleveland Browns getting "Johnny Football" Manziel a few months ago & the Republican National Convention choosing Cleveland in 2016. All signs from the gods favoring Cleveland Biolabs

    Sentiment: Buy

CBLI
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