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Post by Yelk on Feb 16, 2015 5:16:16 GMT
I'm expecting FDA meeting news on Tuesday along with the quarter end. If not then any day as the CEO stated in Q1 will be meeting with FDA and that is ending now. Looking forward to direction (hopefully positive).
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Post by Yelk on Feb 21, 2015 2:03:40 GMT
Well its been quiet - too quiet. I guess my expecting FDA direction this week was too early. I added 3 months to the last reporting date to get 4th quarter > that math was incorrect as I noticed last year was near end of March. So expect direction in the next 1-4 weeks. GL to all holding this - I'm really excited and think they have an amazing unobtrusive product.
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Post by Yelk on Feb 22, 2015 1:27:25 GMT
O.K., so total brain fart. March 20 is end of Q4 not Q1. Lets do this for real.
Calendar:
The following dates are all approximates based on the companies website and are rough estimates but should be most time frames are calculable. We know: Meeting FDA Q1, Bridging study right after, 12 week efficacy study, 6-12 month safety data, expected drug launch timelines.
Here is what we are looking to ahead:
Event:
~April 2015 FDA end of P2 meeting ~May 2015 bridge study start ~June 2015 bridge study end (catalyst) ~July 2015 efficacy study Start ~November 2015 efficacy results (major catalyst) ~November 2015 launch of safety study ~April/Nov 2016 safety results ~Nov 2016 submit application for new drug ~September 2017 drug approval ~Oct-Dec 2017 Drug launch U.S. ~2018 Commercialization in Europe
PPS Projection:
This is an unmet need with an easy to use drug with fantastic efficacy. Target population is conservatively 1 million patients. Current treatment injection is $14 each time. Cynpasis has estimated their strip will be around even or just slightly higher and are looking for reimbursement possibilities. Estimated use per day is 2-3 times.
$15 X 2 = $30/day $30 X 365 = $10950/patient/yr
With this market potential IMO we could see by 2018 commercialization could see $7-$8. That is 3 years and should translate into tripling holdings every year starting this year. It all depends on results. Step 1 waiting to see what FDA has to say in Q1. GLTA.
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Post by Yelk on Mar 2, 2015 6:19:10 GMT
We could start to see a rise towards long anticipated FDA discussions. I think starting tomorrow I will start to accumulate here.
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Post by Yelk on Mar 4, 2015 1:13:30 GMT
Good time to buy on 10% dip today. I'm hoping it goes down more before FDA releases news. Only a small position need to triple before news. Waiting to adjust positions.
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Post by forthefuture on Mar 4, 2015 3:55:20 GMT
I was really hoping we'd hear something regarding FDA interactions by now. I assume they'll include it in their Q4 earnings update.
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Post by Yelk on Mar 4, 2015 4:57:57 GMT
I was really hoping we'd hear something regarding FDA interactions by now. I assume they'll include it in their Q4 earnings update. I want to load up here if I can. I think people underestimate the importance of this guidance. This company has everything going for them and it all hinges on getting smoothly to commercialization. With good news/guidance and an assertive path we could probably see a substantial run-up to data. I wouldn't be surprised to see $3 before data if everything is on track and data is released late this year for efficacy trial. That is a long ways away though - I shouldn't my chickens before they hatch.
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Post by Yelk on Mar 7, 2015 18:17:35 GMT
If this was a revenue company I would sold yesterday. Technical analysis shows strong weakness and a downtrend. However this not the case due to pending news with FDA. The only reason for downtrend is people are getting impatient/nervous at no news. I plan to buy in as we move down - and expect downward movement over the next couple weeks if no news. I'm not expecting news until April so we could see significant downside here. Only reason I can't risk to sell is I have no idea when news is so I'm holding and adding. With proper FDA direction and an exact calendar provided for road to commercialization the stock will spike and trend up IMO as we head into efficacy study. The market cap is tiny and if successful commercialization is as little as under 2 years away.
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Post by Yelk on Mar 7, 2015 18:21:12 GMT
It depends if the safety study is 6 or 12 months. I see no reason stock shouldn't be at $4 if end of year efficacy results support what the last study showed. I believe there is 100% upside to fall of 2015 for the run-up of the 12 week study. I plan on taking profits from now to then on a full position and holding a full position through data.
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Post by Yelk on Mar 11, 2015 1:42:29 GMT
Jason Napodano just tweeted FDA results may be released on March 18th. Might be guessing - but a fair assumption IMO.
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Post by forthefuture on Mar 11, 2015 20:42:21 GMT
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Post by Yelk on Mar 12, 2015 1:14:29 GMT
I am VERY pleased with these results. If they can prove efficacy results in the study we are commercializing status 2017... The share price would be insane. The risk reward for the stock at this level is massive and I plan to buy more if we dip down!
I am most pleased about 6 months safety versus anticipated 12 months. Looking forward to JP update article in a few weeks.
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Post by Yelk on Mar 19, 2015 2:15:32 GMT
If you haven't already read this new article out just today by Jason Napodano I would highly recommend it. One of the best and most extensive he has written here. Rates 75% chance of success and $3 fair value looks like NDA file 2016 with possible buyout. Looking at 4-6X upside in 1 year give or take term. Very favorable risk reward, especially for time frame. We have really good results so far, leadership and good safety profile/easy to use/superior product to competition. I'm looking forward to catalysts progressing in Q2.
I'd like to note we have catalysts coming up faster than expected:
-Q2 start Bridge study -Q2 Efficacy study only 12 weeks long -Q2-3 Results and safety study to start -2016 NDA (possible takeover).
If efficacy is met, we already have good safety so far for this drug - I see a possible 100% conservative upside here 200% optimistic by announcement of safety study start (not that long) 300-500% if we are bought out early 2016 and if not a great increase into commercialization any way you look at it. Lets not jump ahead too far though. Lets wait for efficacy.
At any rate this is an attractive undervalued company with high chance of success with a run-up to start any day. There will be some run-up into the efficacy trial for sure.
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Post by Yelk on Mar 27, 2015 4:32:14 GMT
Stock in a continued downtrend. Worries me a bit but sticking to long term plan. There is no way this is $1 before results are announced IMO, the math just wouldn't add up not only for the value but the probability of success is higher here than usual. My plan is I hold 80% position. Will look to add if it goes lower than expected with final 20% or 10% at a time depending. GLTA here, plan remains long term few months hold.
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madamemagoo
Junior Member
don't shoot mandy magoo!
Posts: 70
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Post by madamemagoo on Mar 27, 2015 19:08:50 GMT
I've been holding since .66 and don't plan on selling anytime soon.
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Post by Yelk on Mar 31, 2015 13:00:19 GMT
Trading was just halted for impending news...
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Post by Yelk on Mar 31, 2015 13:09:31 GMT
I'm not very familiar with these. I assume this is a major good or bad news release? How big would it have to be to halt?
There really isn't any trials going on atm for bad news...
We've been entertaining the idea of a buyout...
I have a full position here so hopefully not bad.
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Post by JHam on Mar 31, 2015 13:28:35 GMT
I'm not very familiar with these. I assume this is a major good or bad news release? How big would it have to be to halt? There really isn't any trials going on atm for bad news... We've been entertaining the idea of a buyout... I have a full position here so hopefully not bad. Could be either. Good luck!
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Post by Yelk on Mar 31, 2015 13:47:55 GMT
I tweeted to JP and nobody knows what's up - not usually a good sign. Nothing for sure yet. Might be another hour or so.
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Post by Yelk on Mar 31, 2015 14:23:58 GMT
Looks like financing went through, good names, no warrants. Looking for official PR.
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