Joe Gantoss

Joe Gantoss
Contributor since: 2012
Sorry for the mistake, posting the $NPSP comment at $ACAD 's article.
As I mentioned on twitter & my TA & Charts website, The 1/2 position that I sold on Sep 20th @ $2.75 with 99.28% .... I bought back on 09/26 @ $2.36 & I'm still holding my position .
Think that we will see a new run-up as we get closer to Nov. as the company will reveal the results of P-III late Nov as their last PR.
You can see the update & follow-up here
http://bit.ly/Qm8ag2
Just for the record, I closed my position banking my profit of 21.74%, I'm not holding through the coming volatile event.
$NPSP reached my price target ahead of the AdCom & exceed to touch the $10.07.
As we know the panel is Tuesday, notes will come out tomorrow Friday, so it will be a volatile event depend on the wording of the documents.
Trade it wisely, and if you are keeping your position through the panel vote, hedge your position with some puts, just in case.
All the best, till the next winning trade
Will keep watching for t re-enter after the panel vote !!!
Just for the record, I closed my position banking my profit of 21.74%, I'm not holding through the coming volatile event.
$NPSP reached my price target ahead of the AdCom & exceed to touch the $10.07.
As we know the panel is Tuesday, notes will come out tomorrow Friday, so it will be a volatile event depend on the wording of the documents.
Trade it wisely, and if you are keeping your position through the panel vote, hedge your position with some puts, just in case.
All the best, till the next winning trade
My First target $8.48 reached today, faster than I though, the price touched the $8.50 point but close @ $8.47 just a cent below the resistance line.
Like to see the volume expanded, it's important a healthy uptrend, we might see some side-way days, but the uptrend is valid.
Next resistance line is the $8.88 line then the 52 weeks high $9.28
Will keep update here & will post updated charts too on my website
http://bit.ly/Oe1UVg
Thanks Wiesemc
Hope the article can help traders to understand the potential and the risk as well, do your DD, know what you are holding & trade it wisely.
Will keep updating the charts here & on my website as well
http://bit.ly/Oe1UVg
As expected, Revestive® (teduglutide) Receives European Marketing Authorization for the Treatment of Adults with Short Bowel Syndrome (SBS)
SBS is a rare and highly disabling condition that impacts patients’ quality of life and can lead to serious life-threatening complications
Teduglutide has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)
No problem,
CDX-011 will not presented at ASCO as we all know already, but a good results and the price will explode
In the other side a normal or bad results, the price will get a hit
SO trade wisely. know and limit your risk
Hi Wiesemc
The first position I started as you can see on the chart @ $3.80 sold half @ $4.80 & the next half with stop loss @ $4.15, Avg. profit 17.61%
The second position with avg. price of $4.022
Will sell before end of the day, considering holding small position through the results, didn't decide yet, but will keep my Aug. $4 calls through
As a trader, I will sell my position before the PR and the results.
It's a risk management, even the upside is huge if the results will be over the expectation, but the risk for a bad data is big too...
So till Wednesday & before the market closing, will sell my shares, might keep some lotto option calls just because I feel it will be a good results, but not enough to keep my hard earn cash through.
Yes, and we will see more action as we get closer to the 5/23, as CLDX will present the topline results from the phase II study of CDX-011.
Hi Wiesemc,
The cretical error has cost CLDX the opportunity to present the data of its breast cancer drug CDX-011 at ASCO, but it cost the shareholders about 20% dropping from $4.78 to $3.97 today.
CLDX has decided to hold a webcast on May 23 and present the topline results from the phase II study of CDX-011.
In the last 4 days the price finds support around $3.90 level, in case & breaking down the last low $3.88 & closing below it, then it will be considered as a bearish sign and creating a lower low.
Still think that there is a good chance to see a run up in the last 2 weeks ahead of the data.
Trade it wisely, and with risk management.
Shane, what is wrong..Look at the charts, it's down from $17.14 to $12.49 on May 03rd, that's only 37% loss in a month for the shareholders.
You have to separate the private investors & traders, from the institutional holders that can hold for long term, and have another look & thesis at the investment world, than the private traders, they are looking for a quick gain.
I still think that we have more of the downside than the upside in the coming few months, till the resubmission that will take another few months, and will cause more pain and losses for the shareholders.
As a biotech trader, I will start looking after MAPP just 2 months after the FDA acceptance of the resubmission and getting the class-II that means 6 months review.
See you there.
Chemistfrog, thanks for your comment
I think it's a good pick very close to the bottom after finding a support line too.
Engi, ATHX is great too, but as a trade and opportunity, NBS is better these days.
It's already up 8% in 3 days from $0.36 to $0.39
I'm looking for the Bollinger bands breakout, that will give a great run after the volatility squeeze released.
manage your risk with stop loss
here is the CEO Dr. Aviezer's answer about the ISRAELI Approval
Q: How long will it take you to get approved in Israel after the FDA approval? Will you be able to sell immediately after FDA approval or do you need to wait for Israel approval?
A: We believe that the approval in Israel will occur closely after the FDA approval. After receiving the approval, we will start transferring patients. Pfizer is ready with patient transition plans in other territories where approval is anticipated, and they will facilitate the process worldwide, with exception of Israel.
Terms
• Upfront payment of $65 million
• Additional near-term regulatory milestone payments of up to $50 million
• Pfizer and Protalix to share net profit and net loss of taliglucerase alfa on a 60% / 40 % basis to Protalix. Certain limited capped expenses.
• Territories
• Pfizer retains exclusive worldwide rights outside of Israel
• Protalix retains exclusive commercialization rights in Israel (1)
• Protalix to manufacture taliglucerase alfa
I received hundreds of DM asking about PLX ahead of the decision date; find it's easier to summarize it here.
The decision should be passed to Protalix on 05/01, it's Tuesday, the company have to report to the sec and hold PR as soon as possible, so they can post it after the closing, or next day morning around 8:00 am EST before the markets opening.
The chances for approval are high, but with the FDA there is no 100%, so be prepared.
The biotech traders are waiting to short PLX after the approval, to enjoy the sell-off after the first spike on the approval news, just like DSCO or AFFY, and after shorting they will satrt bashing PLX with misleading numbers of the future sales and the profits.
but PLX is different as it has very close catalyst and milestone.
1. PLX will receive $50 from PFE, $25M after the FDA approval & another $25 after the EU approval.
2. PLX will get the Israeli Approval too, very quick as the Israeli approval depend on the FDA and follow it, meanwhile, PLX can start selling immediately with a special request to the Israeli Health department, and Israel is a very important market as PLX have 100% of the sales and not sharing it with PFE.
3. PLX will get the Brazilian approval too just after the FDA approval. The Brazilian market is very important. Approval in Brazil could trigger a long-term supply agreement that contemplates transferring certain components of the manufacturing technology to the Ministry of Health of Brazil.
4. Protalix & Pfizer is waiting for the European approval too, the CHMP opinion might be on the next meeting May 21-24, and if they get a positive opinion the approval will come within 2 months.
5. Protalix started the preparation to submit the IND of the Fabry PRX-102 IND to the FDA in the second quarter of this year, so it should be till end of June 2012.
In the other side, in case and Protalix get CRL from the FDA, it will be a disappointing decision to the shareholders, and the price will drop hard, so every trader that is planning to hold through the decision should hedge his position to reduce the risk, Risk Management is very important in the biotech sector for any company waiting for the final FDA decision.
Trade it wisely, and know your limit.
All the Best
Joe
I received hundreds of DM asking about PLX ahead of the decision date; find it's easier to summarize it here.
The decision should be passed to Protalix on 05/01, it's Tuesday, the company have to report to the sec and hold PR as soon as possible, so they can post it after the closing, or next day morning around 8:00 am EST before the markets opening.
The chances for approval are high, but with the FDA there is no 100%, so be prepared.
The biotech traders are waiting to short PLX after the approval, to enjoy the sell-off after the first spike on the approval news, just like DSCO or AFFY, and after shorting they will start bashing the company and might send misleading numbers of the sales after the approval.
But PLX is different as it has very close catalyst and milestone.
1. PLX will receive $50 from PFE, $25M after the FDA approval & another $25 after the EU approval
2. PLX will get the Israeli Approval too, very quick as the Israeli approval depend on the FDA and follow it, meanwhile, PLX can start selling immediately with a special request to the Israeli Health ministry. Israel is a very important market as PLX have 100% of the sales and not sharing it with PFE.
3. PLX will get the Brazilian approval too, just after the FDA approval. The Brazilian market is very important. Approval in Brazil could trigger a long-term supply agreement that contemplates transferring certain components of the manufacturing technology to the Ministry of Health of Brazil.
4. Protalix (& Pfizer) is waiting for the European approval too, the CHMP opinion might be on the next meeting May 21-24, and if they get a positive opinion, the approval will come within 2 months.
5. Protalix started the preparation to submit the IND of the Fabry PRX-102 IND to the FDA in the second quarter of this year, so it should be till end of June 2012.
In the other side, in case and Protalix get CRL from the FDA, it will disappoint the shareholders, and the price will drop very hard, so every trader that is planning to hold through the decision should hedge his position to reduce the risk, Risk Management is very important in the biotech sector for any company waiting for the final FDA decision.
Trade it wisely, and know your limit.
All the Best
Joe
Thanks for your comment.
It's very important to do your DD before investing, that's rule #1
I think that the overreaction and the sell-off after the dilution created a good opportunity especially after creating the support level @ $0.31
Hey ssanya,
ABout the next product, here is a copy from my latest CEO interview,
Q: So now you have enough cash for the Fabry PRX-102 IND submission?
A: This is correct. We are in preparation to submit the IND in the second quarter of this year. We also want to advance the clinical development of the drug PRX-106 (the plant cell protein equivalent to Enbrel), and the Gaucher oral gglucocerebrosidase. We now have the financial base required to advance these programs.
Q: What's new regarding PRX-102 for Fabry disease?
We conducted a pre-IND meeting with the FDA in the 4Q 2011, at which we discussed the initiation of a Phase I/II clinical study. The goal of this trial is to evaluate the safety, tolerability and efficacy of the drug.
Q: So, the submission will be in 2Q 2012?
A: Yes. The IND submission will be in the second quarter. We are not waiting for the taliglucerase FDA approval; these are two different clinical development programs and have no direct connection to each other.
The FDA will decide in few days, the chances for approval still very high in my opinion.
About the hypersensitivity concern, only 6% of the patients developed hypersensitivity reaction, just like Genzyme & Shire drug, so it's not the real issue.
In the Switchover trial, PLX presented long-term safety and efficacy data from the Company's double-blind, follow-on extension study of taliglucerase alfa for the treatment of Gaucher disease in naïve patients.
Eligible patients who completed nine months of treatment in the Company's pivotal phase III clinical trial were offered the opportunity to participate in the extension study and continue to receive taliglucerase alfa at the same dose they received in the phase III clinical trial for an additional 15 months in a blinded manner. Accordingly, the extension trial included two treatment groups; one treated with a 60 U/kg dose and the other with a 30 U/kg dose. The major endpoints of the study were spleen volume, liver volume, hemoglobin concentration, platelet count, and chitotriosidase activity. Twenty-six patients were enrolled in the extension trial which was performed in centers throughout Europe, Israel, North America, South America and South Africa.
Patients treated with taliglucerase alfa in the extension trial continued to demonstrate a statistically significant reduction in mean spleen volume after 24 months, compared with baseline, in both treatment groups.
Protalix after approval will be a target of the big pharma, think PFE will be the first in line, every one will look after the technology.
After the FDA approval, the platform is validated! PLX would have proved to the world that their innovative novel plant base technology is working and can generate approved drugs. So, Taliglucerase is only the tip of the iceberg hiding underneath is the ProCellEx platform.
I think we will see a pop on the news, some profit taking will bring the price a bit down, but the 4.3M shares short, will lead for a short squeeze and take the price to a new high.
Thanks Bimaster,
This news make me feel more confident in the PLX approval.
The US need another supplier & PLX facilities already approved, PLX & PFE have a huge stock on the shelves ready to ship & supply the demand
Chart update
Look at the new chart :- Keep the downtrend as expected, breaking down the $13.02 SL after 7 days heading to $10.54
http://chart.ly/lxd9kgs
Till now, it's in the right direction as my expectation, will keep my shorts
Foxguy, I think that you didn't get my point, I'm just taking PLX as a method to show the history plus timeline & trying to calculate the period of time will take MAPP to resubmit the NDA & get a new PDUFA date.
I'm sure that there is a lot of consideration to delay PLX approval, the way that their technology works, will be a real threat to the big pharmaceutical companies as they can break lots of patents with the plant cells.
I think that PLX have a high potential and will get approved on May 01st
Back to MAPP..They will stay under pressure and the price keep bleeding till the next update, I started calling for short early just after the CRL @ $16.50 , today it's trading @ $12.95, you can read my first article in SA too
http://seekingalpha.co...
dgebremedhin, thanks for your comment and your insight
Even without touching the bigger problem (bioavailability and the formulation) we have to follow the history of a CRL from the FDA and the experience with similar situations, can tell us clearly about the timeline.
I didn't liked the way that the MAPP tried to cool down the CRL and show it as a minor issue that can be fixed quickly, they know that it takes time for the Resubmission, and time is money, and pressure on the PPS as it will take at least a year till the next PDUFA date
MAPP keep the bleeding as expected, nothing will hold the price up, after the CRL, as every one knows the next PDUFA date wont be before a year from today, even the institutions that usually holding for long term will reduce their position and that will trigger even more sell-off
Look at the updated chart, breaking down the uptrend channel then the support line around $13.60 heading down to the $13.02 line, then to $11.95
let's see where it will be on May
click here for the chart
http://chart.ly/rvkk2hq
Thanks Grumann for your comment.
I will look at ARNA in the neat future.
About the charts & TA, it's working well for the regular runs, it helps to get the best entry & exit points around the support & resistance points, but when it's coming to the catalyst date, it's not relevant.
The best way is the combination of both, the TA & fundamentals, and the best is knowing the timelines & procedures of the FDA & the clinical trials, it's lots of Due Diligence, hard work :)
Good article Scott
About PLX, the odds for approval even higher in my opinion, the drug is working perfect for long time, PLX & PFE still supplying the drug to patients across the world, some under compassionate use and some selling under special order like in France & Brazil after the shortage
The Switchover trial show again that it's safe to move from GENZ's drug to PLX's one with no side effect
More than 83% of the companies with Resubmission get approved by the FDA...PLX had the facilities approved too by the FDA
For more in depth and CEO interview read my article on SA
http://seekingalpha.co...
VODEMOUT, you are optimistic and I like that :)
To get better look at the real support & resistance points, I'm moving to the weekly chart.
the price had a real breakout of the triangle, with a positive indicators, MACD & RSI have more to go upward.
The next strong & real weekly resistance is $8.28 then $9.16
Breaking out those points will lead to the last high from the previous RunUp $10.60
If we look at the daily chart we can see a near term resistance @ $7.16 before heading to the strong one
take a look at the Weekly Chart (Click on it to enlarge)
http://chart.ly/jsqkvhm
b.holden, do you mean, today price is around $6.50 ..
If you look at the chart above, the price was $5.86.It's around 11% in a 10 trading days ..That's very good gain,.
I like the TA that it's happening step by step as I mentioned, first the triangle breakout, then the TL retest, today a new high 6.56 and keep going.
I'm looking for the breakout of the $7.16 point
All the best to all PLX holders
Bionic...good point. thanks for posting your opinion here.
I think there is no other way, and today 04/02 we can see the continuous pressure on the price reaching a new lows.
The traders must understand, that during the next year till the new PDUFA the company will keep burning cash, will pay lots of $$ to a consultants to provide the FDA with a reply to all the issues raised in the CRL and have no choice unless new offering & dilution.
My point is a trading strategy with experience of hundreds of same case scenario.
Use the history and the skills, don't stick to a failed trade with hope that it will be OK.
You are missing the main issue or trying to hide it, the procedure of the resubmission is not 2-3 months, I had followed lots of biotech companies that had a CRL, and tried to send that it's under control and will be very fast, but if you read my article again about the FDA policy and procedure, you will understand that it will take around a year for a new PDUFA..That's a long time for traders, not for investors, but meanwhile there is no real catalyst and the price will keep bleeding.
Stay long and watch the price declining, it's your choice.