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Most biotechs struggle to get past phase 2 testing, then struggle to be successful in phase 3, then struggle to get FDA approval. This biotech can't even get through one IND. What does that say for phase 1, phase 2 and phase 3? OUCH!!! I would stay away!
I will tell you right now any other biotech that even has a new entity for instance Rexahn Pharmaceuticals (RNN) only took like 3 months to get an IND filed with the FDA. Even with a new entity like RX-3117.
On the other hand this company has been at an IND For a year or more and still hasn't made any real progress.
Bottom line is Dr. Koos is stringing investors along to keep a huge paycheck. Just go to google and type in "Dr. Koos" and see how many shell companies he has created over the years to collect a paycheck .Do many know that before BMSN there was other names that dealt with refrigerators and clothes? He has been doing this consecutively for years? Why? Well simple pink sheet companies don't need full disclosures like NASDAQ, NYSE, etc. So he can get away with showing nothing that's the bottom line.
Pretty much sums it up. Those investors that sold at a loss or bailed out got duped. The results were great for only 1-month post surgery pictures? You can't tell efficacy of the drug compound only after 1 month. here is what I expect to happen when the 3 - month photos are shown. On the placebo side the hypertrohic scar grows back to its original form looks terrible just like pre-surgery. On the RXI-109 side I expect it to remain at VAS score of 2 or below (where it is in current results). This means that on the next set of pictures it will be a huge difference between RXI-109 and placebo.
new update by company " RXi Pharmaceuticals Presented an Update on the Company's Dermatology and Ophthalmology Franchises"
http://finance.yahoo.com/news/rxi-pharmaceuticals-presented-companys-dermatology-110200883.html
I agree with you. My analysis after examining the data.
cohort 2 RXI-109 showed a better difference than placebo with delayed treatment. Remember this is only 1 month post surgery, meaning the 3 month results should be better. At the 3 month mark I expect the hypertrohpic scar to grow back on the placebo side, and remain lower on the RXI-109 side. All in all the results were good I think a lot of daytraders/shortsellers, and uneducated investors took this down. I think it will bounce back in the coming days!
RXII results should be good, because I don't think the company would add new novel targets for dermatology to the pipeline if RXI-109 using the sd-rxRNA platform wasn't going well. To me it seems bullish and I am all in with the most shares out of any other biotech. I have done my DD and I think Wed should bring good news. GLTA in this!
That's because nobody believes in the CEO Koos. He has been stringing investors along for years with other OTC stocks.
Oh yah this trend is going to continue! RXII expecting phase 2a trial results any day now!
If you read that info they have actually listed Rxi Pharmaceuticals in the bottom most paragraph out of so many that will be attending. It seems to me RXII is gonna get the recognition that it deserves. Honestly I expect some type of partnership in RXII with big pharma before the end of 2014
Reason why RXI-109 Phase 2a will be positive:
I would be inclined to agree with you except you have to take bits of evidence and piece them together to infer what might come out of the results. There are certain information that you and other investors should have taken note. For starters:
1. RXII used a much lower dose than Pfizer's Excaliard in phase 1 yet achieved greater knockdown. Now if you look at Excaliards trials for Scarring you will notice that it had positive phase 2a results in hypertrophic scars and keloids. Therefore we can infer that RXII's drug should do substantially better than Pfizer's Excaliard drug from the previous statement above. It's just putting two and two together.
2. Did you take note what the CEO said during the Jefferies conference presentation? First he said that the results look amazing and heading in the right direction they wanted. But he noted that the results are still double blind. Although can we really infer that a placebo compound (saline) was able to reduce scars dramatically? I think not, I think RXI-109 showed great reduction of scars and placebo probably nothing otherwise Saline in the market would be a goldmine for scars.
3. CEO has been buying every chance he got and has stopped the last 2 months because he can't buy when a big catalyst event is coming within a 2-month period. Now if the CEO was selling a lot of shares prior to the 2 month period then I would be worried but he did not.
4. Closing bell video on NASDAQ the CEO and I hope you listened closely said " that the doctors giving RXI-109 to patients wanted to use it for themselves jokingly. That doesn't sound to me like bad results does it?
5. Finally you have to look at other clinical trials. The monkey trial in itself is amazing because you can see the true power of the sd-rxRNA platform and RXI-109 itself. The company was only attempting to reduce the mRNA of the retina. That was their only goal but the compound was so strong that it spilled over to the front to knock down the mRNA of cornea
I'm glad you are here, because people don't waste their time talking about bad stocks, this means positive phase 2 results are coming for RXII. Thanks for the tip!
I added more shares for Monday in RXII granted there is no phase 2 update. If there is a phase 2 update and positive then my order won't fill. But I have acquired enough shares to where a small rise will net me a lot of money.
I have done my DD on RXII and I like everything about the company the technology platform sd-rxRNA, the science of RNAi, the CEO Dr. geert cauwenbergh, other management team like Pamela pavco etc., the fact that the company has advanced RXI-109 so fast as a small biotechnology company (you don't see that often). Good luck to everyone and hope that the phase 2 update is all good and that much more! GL to all Longs in RXII!
Honestly I'm predicting BMSN will say they have to submit additional data to the FDA and then string investors on for a longer time.
Pending animal data, and other data an IND should only take 30 days to review from the time it's submitted. Straight from FDA website:http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
This company has already had responses back from the FDA so many times so what is the problem? Even with New chemical entities (new drugs) not yet tested in animals or humans it doesn't take one year + to file an IND. I'm sorry but I don't like what I have seen that has transpired with this company, and I feel sorry for shareholders that keep getting stringed along. Also for anyone that hasn't done any DD , the CEO koos also runs another sub penny stock ENTB as well. Something here smells fishy IMO.
New Seeking Alpha Article "Is GW Pharmaceuticals Still A Buy After A Big Run-Up?" http://seekingalpha.com/article/2402575-is-gw-pharmaceuticals-still-a-buy-after-a-big-run-up
Once the phase 2 results are out wall street will understand the true value of RXII. Until then I remain patient and know that RXII's time will come soon enough!
RXi Pharmaceuticals Expands Clinical Program with Initiation of Third Phase 2a Study with RXI-109 for Treatment of Hypertrophic Scars
http://finance.yahoo.com/news/rxi-pharmaceuticals-expands-clinical-program-110200085.html
Didn't like all the bearish articles out there today but I found a good one that showcases the company's future with NASH
"Galectin Therapeutics Gets Punished For Phase 1 Trial, But Wall Street Is Missing The Point"
http://www.biotechpicklist.com/galectin-therapeutics-gets-punished-for-phase-1-trial-but-wall-street-is-missing-the-point/
pretty much sums up the company. It doesn't take that amount of time it has to file one IND. The phase 1, phase 2, phase 3 take time, but an IND doesn't take this long. I'm sorry to say but there are huge red flags here.
That's why this trades on the OTC. Stocks that trade on the OTC have less posting requirements and transparency than NASDAQ and NYSE stocks. OTC stocks can do whatever they like with no restrictions from OTC.
Weird article from AF anyways I wrote my own Article I hope you all like it!
"Inovio Pharmaceuticals Posts Positive Phase 2 Cervical Dysplasia Data, Platform Now Validated"
http://www.biotechpicklist.com/inovio-pharmaceuticals-posts-positive-phase-2-cervical-dysplasia-data-platform-now-validated/
Anyone else adding more shares? I'm about to buy another 1,000 shares this coming week! I want to load up before the results!
I'm not sure how much people are versed with biotechnology stocks but it doesn't take 17 months to file one IND to start clinical trials. if you look at Inovio, Rexahn, Heck even HEB they file INDS a lot faster say a few months. 17 months to get one IND approved is ludicrous and ridiculous.
I'm just not convinced that Koos has interest shareholders in mind. It doesn't take this long to file an IND. Heck ACTC is already in phase 2 trials although they have been in phase 2 for a very long time. BMSN hasn't even gotten their IND achieved after such a long time? I don't have any hopes for BMSN to accomplish its IND goal.
"Why I’m Still Long Rxi Pharmaceuticals After Recent Developments"
http://www.biotechpicklist.com/why-im-still-long-rxi-pharmaceuticals-after-recent-developments/
RXi Pharmaceuticals Appoints Peter Campochiaro M.D. to its Scientific Advisory Board
http://finance.yahoo.com/news/rxi-pharmaceuticals-appoints-peter-campochiaro-110200182.html
Pfizer Has It All Wrong, Should Look Into New Viable Acquisitions
http://seekingalpha.com/article/2298335-pfizer-has-it-all-wrong-should-look-into-new-viable-acquisitions
Yep very good news, because intelligent people can deduce that things in Europe must be going really well with RXI-109 in scarring patients otherwise why would they need a bigger facility? Celldex had expanded to a bigger location and reported positive results thereafter. I see this move to a bigger location as a positive because I think they must have seen some of the double-blinded photos for RXI-109 in hypertrophic scarring. Good luck to all, but things are shaping up nicely.
http://finance.yahoo.com/news/rxi-pharmaceuticals-celebrates-expansion-operations-110200298.html
RXi Pharmaceuticals Set to Join Russell Microcap Index http://finance.yahoo.com/news/rxi-pharmaceuticals-set-join-russell-110200114.html
Filing an IND doesn't take that much time. INO, IMUC, NWBO, RNN can file an IND and be done with it in a few months. BMSN has been at this IND For too long IMO. That's why I don't buy into this stock. I mean it's an IND they are attempting to get not FDA approval or phase 3 initiation. If they take this long for an IND ( if it ever happens) imagine how long it will take to run a phase 1 trial and so on.
As of right now CEO stated last presentation mid 2014. So we should get an update soon. If I had to guess I would say July/August 2014. But we will find out soon enough!
I agree look at other biotechnology companies they put in an IND to the FDA like IMUC, NWBO, INO etc. they get it done instantly. BMSN doesn't get anything done and strings people along for years that an IND will eventually be approved.
If it takes BMSN this long just go get an IND approved (if it ever gets approved) imagine how long phase 1 and phase 2 trials will take. I think the CEO here is just stringing people along to keep a salary IMO.
RXII Pharmaceuticals on Preliminary list to be added to Russell Microcap. Scroll down to the "R" section its under there. Hopefully it will stay till the last list on June 30th.
http://www.russell.com/indexes/americas/tools-resources/reconstitution/additions-deletions.page#indexes
One thing to note is that those price targets are just with the company's pipeline and cash on hand. That doesn't take into account positive phase 2 results of hypertrophic scars. With positive results of hypertrophic scars expect analyst PT of at least $100 per share.
Endocyte Fails Ovarian Cancer Trial, Now What?
http://seekingalpha.com/article/2263293-endocyte-fails-ovarian-cancer-trial-now-what
RXII Key Highlights for Jefferies Healthcare Conference Presentation
1. Because of LPC deal RXII now has enough cash until Q2 of 2017
2. Pictures are coming in for phase 2a hypertrophic scar results and trial still double-blinded but either RXI-109 is dramatically reducing scars or placebo is. My assumption would be they are seeing better reduction in scars with RXI-109 and not placebo that means the results are positive.
3. New move to lab will be complete by Fall in which time they will announce other phase 2 clinical candidates
4. Also the new move to new lab will allow company to create topical form for RXI-109 because it is soluble. Company is excited about this because this brings RXII to a new level as a company
5. Phase 2a breast scar revision surgery study was supposed to start Q3 2014 but being moved to Q4 2014. But this is good news because company has decided to expand on this study and target other parts of the body other than just breast scars. That to me means RXI-109 is working well and that should be construed as bullish.
We are golden have a new analyst price target of $8 , other analyst gave it $9 per share target. Tomorrow at 8:00 a.m June 3rd is Jefferies Conference for more exposure. A plus would be some news but we will have to wait and see!
RXi Pharmaceuticals to Present at the Jefferies 2014 Global Healthcare Conference
http://finance.yahoo.com/news/rxi-pharmaceuticals-present-jefferies-2014-110200790.html
I'm buying more shares for tomorrow gonna load the boat these prices are a steal for long term. The sd-rxRNA is a self delivering RNAi tech that will revolutionize RNAi