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Thanks TOB...much clearer now....so what is your best guess on results in terms of timing (interim or otherwise)?
I have seen that on the clinical trials.gov site, but what is odd is there is only 60 patients in the phase II and there are reportedly at least 3 sites enrolling and maybe up to 5 sites (if they expanded as noted in a previous PR). The trial includes various endpoints but the duration of this is noted as 11 weeks and 7 weeks. If enrollment started May 26th, we are already past the 11 week point for some enrollees....I cannot imagine why this would be scheduled to end roughly 16 months from now if the actual period of dosing is so short. Do you agree Cabel?
Me too Karin...I have been saying for a while now that I believe B-OM could be significant in the short term due to the shorter nature of the trial and the unmet need......if it works like they think it will and then P happens to work as well, look out!
Youssef, thank you very much for your efforts....in the back of my mind I had wondered whether the B-OM Phase II results would be the deciding factor on moving forward with a partnership since B-OM should be much shorter term than the phase III for B. It makes sense that if the B phase III gets started soon and the B-OM results are good, that a partner would be appropriate at that time. This seems to be a much shorter time frame than I had imagined as I was thinking we had to wait until the end of the B Phase III (which I guess could still happen). I am planning to visit Boston in September and may try to stop in to CTIX but I don't want to be a pain if they are getting a lot of visitors...I guess I will see how things are at that time.....thanks again!
Exactly!
Sun....some of your points may be right (although I would not characterize them as you have), but the get rich quick comment is not accurate....I have been invested in CTIX for years and have not gotten rich by any means.....I believe in the science and any information from a Phase I trial (especially K) is important to me from a comfort perspective (whether it be lack of side effects or early indications of possible efficacy)...if you read my post from earlier this morning, I am here for the long term to see how the science plays out...I admit that a quick upswing in the PPS due to a surprise would be great and welcomed, but in reality I understand that all the waiting for trial progression and dealing with short attacks, etc. is the price paid for this type of investment. I can tell you that cancer has touched my family and I would not wish any additional suffering or false hope on anyone....but I have a friend that was recently investigating getting into the K trial and clearly did not qualify (he was not advanced in disease enough)....he specifically asked me to keep him posted on any news as it was a great comfort to him to hear about progress with new drugs for his disease...
11 months...stabilized and very minimal side effects....all at once per week dosing (3 out of 4 weeks per month) that has not been optimized....I think they may be on to something here!
The hit piece did some damage, but I think we will recover from it in the short term before we get any significant news. I am planning to hold every share until we get some additional clinical trial results/developments. I want to be here when the B-OM and P phase II results are known and I also want to be here when the B Phase III gets going. Not to mention the completion of Phase I for K and start of Phase II. So, the price fluctuations while uncomfortable, are not causing me to rethink my strategy....I want to see what the results of the science will be on many fronts before I make a move.
I believe tomorrow will be 11 weeks since the start of the B-OM Phase II trial (which was May 26th according to the PR back then). I wonder if we will hear anything soon or whether the enrollment needs to be more significant first. I for one am very anxious to hear Phase II results. My father suffered tremendously from OM during chemo/radiation and ice chips were the only thing available at the time. I am keeping my fingers crossed that B-OM will provide much relief to many patients.
I agree Dane....if Leo is getting any indication that the B-OM trial is going well after close to 10 weeks of the trial, it would be logical to spend the money to establish agreements with additional sites and proceed further. I think this is a strong indication that B-OM is doing what they thought it would and is not a fluff PR if one reads between the lines. JMHO
Thanks Karin....keeps everything in perspective. Let's hope the B-OM trial is a homerun and the adaptive trial design allows for Phase III sooner than we think....then you will have to update your graph again to show two phase III indications...come to think of it, how will the graph look when a BP partner is announced?
Yes...he has conned the FDA into QIDP and orphan drugs status and Dana Farber out of significant funds for the K trial...can't be the science, must be all the BS.
I'm with you Chuck....a lot of catalysts coming up and I don't mind waiting until the price moves due to the science and progression of trials....recently I have been distracted from this stock due to another promising stock for AD and as a result, it has given me more patience with this one...I can wait however long it takes for the true value to arrive here...
I had the same thought akamaii....SR*T has the same patient anecdotal evidence and the community wants access to their drug so badly. This could explode if there are results that confirm the initial indications later this year and patients continue to improve in the eyes of their families and caretakers....
Nice article and spreading the word on our three (actually four with B-OM) drug pipeline biotech gem!
I wonder how much interest Dr. Missling is getting in terms of merger or acquisition.....I just read an article talking about the failure of Biogen's alzheimers drug (and a few other drugs in their pipeline) and the CEO indicated that they will be aggressive about adding drugs to their pipeline...seems like they would look very closely at our little gem....if Pfizer or someone else has not already made a move to get us :)
I think the seeking alpha article is out, but I cannot access it...
we should be well above $10....look at inotek...up over 200% on announcement of plans to start a PIII on their only drug....
The difference between $4 and $3 is whether it is the "bid" price or the "closing" price. For the capital markets tier, there is no $4 closing price requirement. See the link below and look at Page 9 for Nasdaq Capital Markets.
https://listingcenter.nasdaq.com/assets/initialguide.pdf
If Leo was told it was $4 and we are not uplisted soon, then the bid price has to be $4. I don't know how that works though......do we only need to touch it once during the day?
Check it out now...up over 150% on plans for phase III...
Some new discussions/comments on AVXL on seeking alpha from Kanak Kanti De.....says his full article is coming out later today.
I agree....Inotek announced FDA approved their plans for a phase III and they are way up today. They have one ocular drug in their pipeline....maybe it's related to market cap and outstanding shares and the fact that they are on the NASDAQ, but we have four potentially huge drugs in our pipeline....does not make sense to me..
Glad you are here....which one of our little gems with reach $20 SP first?
Great post TOB....I plan to be on that bus as well....
PR is out....its working!
JohnB...it seems odd to me that if we did not meet the operating history criteria that we would be allowed to keep the application pending as opposed to re-applying when that time requirement was met. If that was the case, I would hope Leo would have stated that we have another 6 months of operation to go before we can re-apply as opposed to just sitting on a pending application. When the price thresholds are not met, I understand that some will do a R/S and others will wait on catalysts or come other way to increase the price. You raise some good points, but I hope you are wrong.
Youssef...I am not 100% certain but my understanding is that the requirements are either 5 days or 90 days depending upon the criteria you apply under. I believe we would be subject to the 5 day requirement as CMC pointed out in his earlier post as well.
J...if you look at the uplisting requirements, there are two thresholds for the capital market tier that are noted as one or the other...one is a bid price of either $3 or $4 and the other is a closing price of $2 or $3...we have had a closing price of $3 for over 5 days and that is what I was told is the criteria.....
I believe you are correct CMC....
Indeed it would.....
What is interesting is there are two ways to meet the requirements.....one is a bid price of $3 or $4 (depending on category of qualification) and the other is a closing price of $2 or 3$ (there is no $4 closing price threshold)....from what I gather, the closing price can apply to us and it is $3. I am no expert on this though....so take what I say with extreme caution....others are probably better equipped to weigh in...
Someone I trust told me that the 5 day clock was accurate for capital market tiers that rely on more than the market cap threshold and that the $3 closing price applies....
The train has left the station....5 days above the $3 closing price happened 15 minutes ago,.....arriving at uplist station next!
It's possible that we have only 20 minutes until the uplist requirements are met....stay strong longs!
The results from B-OM and P Phase II will preempt any efficacy results for K ....I have been saying all along that the ongoing B-OM trial is critical for CTIX....if it succeeds (and we should know by the end of the year) as in the pre-clinicals, we will be off to the races because it will reconfirm Menon's abilities to interpret pre-clinical to human trials! Come on B-OM, be a homerun for us!
I bet we rally into the close today....I predict $3.61
Great post LL!
Agree Sox....we know that Leo and Dr. Menon do not want to take B to commercialization and we know that they were of the opinion that Phase III had to be in progress in order to get the best price on a partnership/deal on B. Ultimately, that is what I had hoped for when they were awarded the stalking horse bid.
I do think this company is way undervalued when you consider what is ongoing currently; B-OM Phase II, P Phase II (on July 28th), B-Phase III and K nearing a Phase I completion (and no safety issues).
Agreed....considering that by the end of July we will have a Phase III for B, a Phase II for B-OM, and Phase II for P and we are approaching the end of Phase I for K (perhaps a Phase II with U of B)....all ongoing....If I were BP I would certainly be interested in augmenting my pipeline with these indications (a $5B bolt-on would be acceptable:).
This was a great surprise this morning...thanks Eric for being on top of this early! This little gem of a company is really starting to move and with Leo reminding everyone of the complete update coming shortly in this PR, I believe he is extremely positive about what that will include. If FDA has given the green light for the B Phase III, that will be three significant FDA thumbs up for CTIX which I believe bodes well for the future. My gut feeling is that the wait for a big move will soon be over!