I was too late selling CRXX yesterday opened at 2.28, now it's down so I may have to hold till Sept 23rd. I think I've done a fairly well DD and confident it will get approval on the review and on PIII results and existing sales is a confidence booster.
However, is there anything, anything at all you guys have uncovered that can jump a surprise at us on the review?
doesn't anyone sleep ???
quite honestly i'm not really sure what the outcome will be, but if the capsule improvements were worked out with the fda, i see approval...and a 4-5 pps
still holding neph ((have taken a large position in IMGG, cc today at 12 pacific time--i'm hoping for fda pics submitted & on for final fda decision, great buyout opportunity.))
capsule improvement, that's the thing... this is very telling "EXALGO bioavailability is not affected by food, and its extended-release properties are maintained in the presence of alcohol with no acute dose dumping of hydromorphone."
Anyway, stock trading is halted for CRXX today .. by the time it open, too late.
MY2 if you weren't able to sell yesteday, I think, you will be happy today. It will be approved.
Finally, the FDA doc;
1. crushing the tablet, they address this thru education and labelling.
2. EXALGO bioavailability is not affected by food, and its extended-release properties are maintained in the presence of alcohol with no acute dose dumping of hydromorphone.
What are your thoughts? Mill.doug I think subscribes to the FDA meeting so he can hear the meeting and decide on to go...
Hi Jayree - I see no reason for non-approval as it was previously approved and issues have been addressed. I will look for low dip this AM and see if I can be back in around $1.60 or less. You're fortunate that you got out ahead! GLTU Always! My2
Like other opioids, EXALGO has the risk of overdose, misuse and abuse, which must be considered when the product is prescribed, administered and dispensed. To minimize these risks, EXALGO should be prescribed to the appropriate opioid-tolerant patient population. EXALGO is therefore contraindicated in the management of acute or postoperative pain, and should not be prescribed to treat mild pain. It is important that the initiation of dosage is individualized for each patient being prescribed EXALGO with appropriate conversion from other pain medications and subsequent dose titration in order to properly manage analgesic relief. Patients being considered for EXALGO or any other opioid should be assessed for their clinical risks for opioid addiction or abuse, and should be monitored for signs of misuse, abuse, and addiction. Patients should be counseled regarding the risks of using EXALGO and the importance of not allowing anyone access to the medication.
In conclusion, the data presented in this Briefing Document demonstrate that EXALGO is effective in controlling pain over a 12-week period in opioid-tolerant patients with moderate to severe chronic pain using a variety of predetermined measures of efficacy. The safety profile across the EXALGO clinical development program is well-understood and is similar to other strong opioids. The primary risks of overdose, misuse, and abuse will be addressed through a comprehensive REMS program. EXALGO will provide an option for clinicians who treat opioid-tolerant patients whose chronic pain is not adequately or optimally controlled by their current opioid therapy. Overall the benefits of EXALGO for patients exceed the risks associated with this new formulation. The risks of EXALGO can be reduced, detected and managed through the comprehensive EXALGO REMS.
Overall, the data demonstrated that the EXALGO formulation provided relatively stable blood levels of hydromorphone compared to IR hydromorphone over a 24-hour dosing interval with less frequent dosing. The same total daily dose of the EXALGO formulation administered once a day resulted in the same total hydromorphone exposure to that of the IR formulation administered 4 times a day. The concomitant use of alcohol and EXALGO, as well as the intake of food, did not alter the extended release profile or result in significantly different total exposure. Furthermore, results from an abuse liability study demonstrated generally lower drug liking for the formulation within the first 4 hours after a single dose, when compared to the IR hydromorphone formulation.
congrats on BIEL! I sold on the earlier run so what i've left tis just 100,000shares. Almost free shares so I'll see this thru the approval.
Was too agitatedly monitoring crxx selloff yesterday...
Hi Jayree: Yes taking profits is always the safe play! A bird in hand......
I haven't had much time today to do much DD. I will definitely look into your leads. I sold 80K shares of BIEL today at .0114 for a tidy profit.
I also recommend buying KV Pharmaceutical (KV.A). They have been a powerhouse generic pharmacuetical company based in St. Louis and ran into problems last Dec with ex CEO who ignored FDA warnings about quality control subsequently resulting in KV to have to suspend manufacturing. KV stock prior to the problems was running around $26 PPS. I bought in at $0.54 back in Feb. Cashed out at $2. Been in and out a few times as problems have been getting worked through. I just bought back in at $2.97 on the dip today. KV will make it and I look for some production to resume late this year as they work out their compliance reviews with the FDA. I look for KV to regain at least half it's PPS of $13 by next Spring. If you can buy below $3.20 do it before it's too late.
GLTU! My Best - My2
Good AM Jayree! I actually bought more CRXX yesterday in the late afternoon dip at $2.09. I would expect the PPS upon approval to be in the $3.40-$4.50 range with the usual sell-off to start anywhere in the $4+ range. With the way things have been going lately, I'm not going to get greedy as I have to make up for some money I've lost.
GLTU as always! My2
Just for clarification, you mean hold till Sept 23 review or till approval which is November.
I think I will hold till Sept 23 review then sell (yes, I won't get greedy...same boat here). Then buy back again after sellof hold till November....
TIA... GLTU always!!!