The Seeking Alpha article had some good points today about ACRX management's holdings and apparent belief in the prospect for Zalviso approval. I thought this might cause this price to go over $12.00 today instead the price is down on an up day for the market- go figure. I believe ACRX will be a big winner and % wise is one of my largest holdings. RMTI is my largest holding. What is your thoughts on the Seeking Alpha article?
The great news clinical trials was that the FDA does not require additional clinical trials. Wow we have a drug that has been indirectly approved. Awesome news! The bad news is FDA express some specific concerns about manufacturing and did not approve. The company indicates some of the concerns have already been met and it will take a couple of weeks to respond to the FDA concerns. The has been much discussion about how long this will take. Some people are selling to take a profit, some are selling now thinking they can get back in later at maybe a lower price. The company has already submitted and received a FDA review. Now the are going to amend their application. This is not a new application and the FDA is familiar with the drug so I would not expect the review to take as long as a new application would take. The manufacturing company indicated they were going to move forward with preparing for production. This statement leads me to believe that they think they will get approval for production. How long an amended application takes for approval I don't know. But it sure seems like the company is thinking there is a great chance for approval in the future. I will add to my holdings especially if the price goes lower. The potential for IGXT success is tremendous. Odds for approval are exceptional. The question seems to be when not if. What is the true timeline for approval?
The 6 months fast track applies to approval of the drug . It appears they have already approved the clinical trial results. The hold up is the approval of the manufacturing and labeling of the product. That being said your estimate could be correct. I have not found the rules for the manufacturing to be approved. If you have please let me know where. I have been to the FDA site multiple times.
On Schwab in my IRA account they do not allow you to sell a stock you have bought until the funds for the purchase have cleared. It They sent me a copy of the SEC rules. If you have dry powder in your account from other transactions the rule does not apply. It usually takes 5 days to clear a purchase..
The amount mined and recycled each year is less than the amount used. Each year this goes on makes the Pd supply less abundant. Russia's stockpile has been reduced. Exchange Traded Funds still have a large supply. At sometime in the future there will be a shortage, when that occurs the price will go up quickly. I can not predict when this will occur but we are getting closer to it happening.
PAL has gone from $0.70 down to $0.40. The present price more than adjust for the latest financing considerations.
I bought at $1.04 two days ago. I would expect it to go to $1.04 or more by tomorrow. Now that many of the shorts have covered and some of them are going long. We are closer to approval than we were on Tuesday. I hope many of you bought the dip, I did.
Thank you for your reply. Gleevec is a new drug. Calcitriol is a generic. I did some more research on the FDA site. PDUFA in 1992 revised in 2002 indicates the FDA goal is 6 month for fast track and 10 months regular track. Info was last published 2011. I could not find any answers for a generic drug which already has a track record for the patented drug. It appears FDA is way beyond their goal and this is for a generic drug.
Calcitriol, Rockwell's low cost generic vitamin D, application was submitted April 1, 2013. It was granted expedited review by the FDA. In October this board was indicating we could hear any day now. Well October, November, December, and now most of January have gone by with no news. What is the normal amount of time for FDA to approve a drug on expedited status?
The first article was written prior to the new guidance. The new guidance lower amount of Pd produced from 200k-250k ounces to 175k ounces. That is lower by 25k-75k ounces. At $750/ounce that is a reduction of $18.7-$56.25 million/year. Second the new shaft was suppose to reduce mining cost by a couple a hundred $/ounce . Each $100/ounce means a dramatic difference in revenue. $100 times 250k ounces equals $25 million. $200/ounces = $50 million. The guidance made a big difference. I am still long but I do understand why the articles differ greatly .
I hope you are right since I am still long. At the present time I can get back in at a lower price than what I sold at. I bet on the new management and to their credit they did complete the shaft. The problem is PAL at the present time faces a cash flow problem in the near term. They are working on solving the problem. The last deal with BAM was very expensive. PAL has tremendous potential but what is it going to cost them this time around to handle the near term cash flow problem? We are at 19% interest rate already. What is next? This uncertainty may cause the pps to drift lower until there is more clarity. The is always an outside chance of a white knight coming along. And management is working on securing additional funding which might come through any day now. Until then it is a wall of worry.
The last time Seeking Alpha wrote an article about PAL needing additional $ the pps went down to.38 cents. I am still long but I sold some today to be able to pick up more at a lower price if the pps goes down like it did last month.
I bought some more shares of RMTI near the close today, I had to sell some shares of another stock to buy the additional shares of RMTI. I will continue to watch RMTI closely, according to messages on the RMTI board E Trade has changed its margin requirements for the stock. A FDA ruling on Calcitrol is long over due. I added to my position in KERX last Friday. Finally I added to ACRX two weeks ago.
I added near the close. The price is getting to be too compelling. 7analyst list this as a buy and one list it as a sell. I had to sell shares of another stock to buy more RMTI but I now believe RMTI has has tremendous up potential from here.
Aa lot has happened since November and the first part of December. We have had new drilling reports , communication that we will be updated in January, and news about financing has occurred If you are expecting information tomorrow you are. Probably going to be disappointed. January's update is crucial
I copied this from the Charles Schwab website. Brean Capital initiated coverage on Rockwell Medical Technologies (NASDAQ: RMTI) with a Sell rating and a price target of $4.00.
"Sales of Rockwell s drugs have been stagnant ($60 million, $49 million, and $50 million in 2010, 2011, and 2012, respectively) and we project flat future growth," said analyst Jonathan Aschoff.
"Triferic did not appear to reduce total ESA use versus placebo in the PRIME trial, and did not reduce ESA use versus baseline, by contrast to what is seen with IV iron and Zerenex. The CRUISE trials had a questionable design that we view as unlikely to result in approval. Both CRUISE trials did not allow IV iron use or changes in ESA use, which is utterly inconsistent with current dialysis center practice under bundled reimbursement. More than 80% of the patients in all CRUISE arms did not complete the 48-week treatment period, making the primary endpoint evaluation period (defined as the last 1/6 of time on treatment) highly variable among patients. A key employee termination and resulting lawsuit further speaks to inadequate Triferic testing, in our view, where a former VP of Drug Development and Medical Affairs warned Rockwell that its Phase 2b trial did not adequately show efficacy or dose-ranging information to proceed directly to Phase 3," he added. WOW! If you have followed RMTI over the years and have read the reports of the results of the trials this analyst appears to be way off base. I am long RMTI and long KERX I believe both have great potential. If you allow IV iron use or changes in ESA use your trial does not enable you to find out if Triferic is effective. The phase three results showed that it was effective! The VP did not win his case and the phase three results indicate that he was wrong. The safety results were excellent for this Cruise trials. Many other analyst have indicated that Triferic has a good chance to be approved. This analyst likes KERX which makes Zerene