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runncoach

07/24/19 12:49 PM

#12739 RE: InTheTrenches #12738

Thx for that. I'll compare a few notes i gathered and get back to you. Very similar take from what i heard
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bellweather1

07/24/19 1:08 PM

#12740 RE: InTheTrenches #12738

Thanks ITT-Very thorough and concise summary of the Shareholders Meeting...Much appreciated!:-)
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Battle Ready

07/24/19 1:17 PM

#12741 RE: InTheTrenches #12738

Great stuff InTheTrenches!!! I wish I had been there, it would have been nice to meet you!
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Alzy B

07/24/19 1:26 PM

#12742 RE: InTheTrenches #12738

Excellent synopsis ITT. Thank you!
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Whoopddew

07/24/19 2:17 PM

#12746 RE: InTheTrenches #12738

Thanks for taking the time to share that
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runncoach

07/24/19 3:17 PM

#12749 RE: InTheTrenches #12738

Trenches from what I heard, folks were most pleased with Ryan about the strength and position of the IP. "Orange book" would be a big deal and from what I understand there have been some recent (at least this calendar year I suppose) moves made to strengthen and lengthen the company's patent exclusivity and that Ryan and their hire a few months ago are very much into that focus. On the whole I think he was viewed as impressive.

I did get the feeling (and perhaps feeds into a little concern I have with the CEO) that Ryan is a nuts and bolts and the drug will take care of itself as far as long term share price issues kind of guy. I heard that he did mention that they have several different IR/media groups currently and had hoped to to put at least some focus on retail investors but had been somewhat disappointed in that regard. While I understand what he is saying, and with quite a few small caps that I've been involved with, that when you are a pre-revenue company you have 2 assets. One is your IP or service you provide, and the second in your stock. In Ryan's former job he never had to worry about money or raising funds. IMO (and was posted many times over last year) not only did we get diluted more than we should have, but the company held onto the peer reviewed data and other news until after the agreement was complete while the share price was dropping only adding to the dilution. Water under the bridge perhaps but we still struggle with the structure of that deal to this day as shareholders. You can't give 1:1 shares and warrants and not expect money to not be taken off the table in a risky AD space. IF we pull back to the mid 4s where the financing took place, then that will be reason IMO. A pre-revenue company needs to have its share price as high as possible at all times. Sorry for the minor rant but I'm not sure I'm convinced he or IR have yet to learn the lesson. Let's hope so. I hope we get that chance. Thanks again.

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runncoach

07/24/19 3:44 PM

#12752 RE: InTheTrenches #12738

I think your "subgroup" thoughts are interesting as well. Not only did Ryan mention BP and 3rd parties closely watching results, Battle Ready posted similar comments made at the Maxim forum. We are a 6-8 employee company so I don't think anyone truly thinks it will be these few folks that eventually and by themselves bringing this drug to market. One of the obvious opportunities to partner and/or license out the drug will come after this upcoming data readout. The clarity and impact of the results will likely dictate any terms and this is where Ryan will get the opportunity to earn his pay....so what do we potentially have to work with?

You pointed out subgroup analysis. This is where the confirmation part of the trial really helps us out. We don't have to do a million things to see who it helped or didn't. We have 2 groups stratified into moderate to severe to severe in category. One with MMSE scores 4-9 and the other 10-15. That's essentially it. Is it possible one of the 2 groups performs considerably better than the other? It certainly is but it hasn't in the past. N was small however so this is one thing to look forward to. If the more moderate group performs better it would certainly lead in the direction that the earlier the treatment the better or that it may take longer dosing to help the more severe or that the most severe may be too far gone. Several options. If the more severe do better then I suppose you could say that their improvement over this short trial is easier to see because they were so bad off. The hope that we are looking for is both groups score better than placebo as they did in the 94% improved total population of the last small subgroup. If we get 80%+ I think we'll have a much better shot at a single pivotal P3 trial. IMO the above are essentially different outcomes for subgroup analysis.

Now the other factor to consider is the primary vs secondary measures. We have weeks 5,9,13, and 15 to look at with 13 being the primary measure. Last trial we hit stat significance on all data points in the non memantine population but it did get even better at week 15. Is it possible we hit on multiple endpoints that are secondary but not week 13 for some odd (placebo spike or other) reason. Anything's possible but if multiple endpoints are hit, especially later in the time progression the company would be fine IMO. Memantine failed primary measures in multiple trials fyi.

I still haven't found a reason or opinion or anything else that would lead me to believe we wouldn't have success in at least one of the two subgroups (I see no reason not both) or that we would fail at week 13 or 15 so IMO I think Ryan will have plenty of interest to work with after results. If not we would unfortunately join a long list. We'll know soon.
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Doc328

07/24/19 5:21 PM

#12765 RE: InTheTrenches #12738

Thank you for the notes. Was there any mention of the status of synthetic bryostatin?