IntelliPharmaCeutics – IPCI - - Hot Stock - - 2015 – 2016 (Seite 249)
eröffnet am 04.02.15 10:20:01 von
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ID: 1.207.106
ID: 1.207.106
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ISIN: CA4581733090 · WKN: A2N5Y4 · Symbol: IPCIF
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Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 10,000 | +25,00 | |
| 6,0000 | +25,00 | |
| 0,7113 | +21,90 | |
| 0,6400 | +18,52 | |
| 1,1100 | +15,70 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8410 | -17,06 | |
| 9,7200 | -19,60 | |
| 4,0000 | -27,27 | |
| 2,7280 | -29,14 | |
| 14,510 | -32,32 |
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Sehr gute Nachricht für IPCI endlich wurde ein weiteres Generika zugelassen .Trotz guter News sollte man mit dem Einstieg warten denn IPCI ist knapp bei Kasse und könnte diesen Kurssprung für eine KE nutzen .
Intellipharmaceutics granted approval for generic levetiracetam
http://thefly.com/landingPageNews.php?id=2333597&headline=IP…
Intellipharmaceutics granted approval for generic levetiracetam
http://thefly.com/landingPageNews.php?id=2333597&headline=IP…
@hottest
schön, dass du noch dabei bsit
@pflicht
schade, dass du nur noch mit halbgas fährst
@all
Sorry, es gäbe viel einzustellen, aber mir fehlt einfach die Zeit, hier unermüdlich zum posten.
Aber bald wird dieser thread zum Selbstläufer.
Soll der NBI doch "abkacken", wir machen unser eigenes Ding.
IPCI hat sich beim Bioboom nicht geschert um die steigenden Kurse, gut dass sie jetzt auch unabhängig von diesem Index laufen.
Ziel: 10 USD bis Jahresende (minimum
)
Die Meldung sollte mind. 20% wert sein, viel Spaß.
Intellipharmaceutics Announces Successful Bioequivalence Results for Abuse Deterrent Rexista™ Oxycodone XR
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone XR (abuse deterrent oxycodone hydrochloride) extended release tablets, dosed under fasted and fed conditions, had demonstrated bioequivalence to Oxycontin® (oxycodone hydrochloride) extended release tablets as manufactured and sold in the United States by Purdue Pharma LP. The study design was based on United States Food and Drug Administration (“FDA”) recommendations and compared the lowest and highest strengths of exhibit batches of the Company’s Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The results show that the ratios of the pharmacokinetic metrics, Cmax, AUC0-t and AUC0-f for Rexista™ vs. Oxycontin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%.
The Company had earlier announced, in March 2015, that topline data results of three definitive Phase I pharmacokinetic clinical trials (single dose fasting, single dose steady-state fasting, and single dose fed), conducted on pilot batches of the Company’s Rexista™ Oxycodone XR, all met the FDA bioequivalence criteria when compared to the existing branded drug Oxycontin®.
The Company had also earlier announced, in May 2015, that the FDA had provided the Company with notification regarding its Investigational New Drug Application (“IND”) submission for Rexista™ Oxycodone XR. The notification from the FDA had stated that the Company would not be required to conduct Phase III studies if bioequivalence to Oxycontin® was demonstrated.
Having now demonstrated such bioequivalence for its Rexista™ Oxycodone XR product to be marketed upon FDA approval, the Company intends to complete the regulatory filing requirements and file a New Drug Application (“NDA”) for Rexista™ Oxycodone XR with the FDA within the next 6 months in accordance with the NDA 505(b)(2) regulatory pathway. There can be no assurance that the FDA will ultimately approve the NDA for the sale of Rexista™ Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
“We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin®. This enables us to accelerate the development and commercialization of our abuse deterrent Rexista™ Oxycodone XR product candidate without the need for costly and time-consuming Phase III efficacy trials,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. “We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction.”
Rexista™ Oxycodone XR
Rexista™ Oxycodone XR is the Company’s non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required. The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently or intentionally co-administered with alcohol. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting or snorting.
schön, dass du noch dabei bsit
@pflicht
schade, dass du nur noch mit halbgas fährst
@all
Sorry, es gäbe viel einzustellen, aber mir fehlt einfach die Zeit, hier unermüdlich zum posten.
Aber bald wird dieser thread zum Selbstläufer.
Soll der NBI doch "abkacken", wir machen unser eigenes Ding.
IPCI hat sich beim Bioboom nicht geschert um die steigenden Kurse, gut dass sie jetzt auch unabhängig von diesem Index laufen.
Ziel: 10 USD bis Jahresende (minimum
) Die Meldung sollte mind. 20% wert sein, viel Spaß.
Intellipharmaceutics Announces Successful Bioequivalence Results for Abuse Deterrent Rexista™ Oxycodone XR
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone XR (abuse deterrent oxycodone hydrochloride) extended release tablets, dosed under fasted and fed conditions, had demonstrated bioequivalence to Oxycontin® (oxycodone hydrochloride) extended release tablets as manufactured and sold in the United States by Purdue Pharma LP. The study design was based on United States Food and Drug Administration (“FDA”) recommendations and compared the lowest and highest strengths of exhibit batches of the Company’s Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The results show that the ratios of the pharmacokinetic metrics, Cmax, AUC0-t and AUC0-f for Rexista™ vs. Oxycontin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%.
The Company had earlier announced, in March 2015, that topline data results of three definitive Phase I pharmacokinetic clinical trials (single dose fasting, single dose steady-state fasting, and single dose fed), conducted on pilot batches of the Company’s Rexista™ Oxycodone XR, all met the FDA bioequivalence criteria when compared to the existing branded drug Oxycontin®.
The Company had also earlier announced, in May 2015, that the FDA had provided the Company with notification regarding its Investigational New Drug Application (“IND”) submission for Rexista™ Oxycodone XR. The notification from the FDA had stated that the Company would not be required to conduct Phase III studies if bioequivalence to Oxycontin® was demonstrated.
Having now demonstrated such bioequivalence for its Rexista™ Oxycodone XR product to be marketed upon FDA approval, the Company intends to complete the regulatory filing requirements and file a New Drug Application (“NDA”) for Rexista™ Oxycodone XR with the FDA within the next 6 months in accordance with the NDA 505(b)(2) regulatory pathway. There can be no assurance that the FDA will ultimately approve the NDA for the sale of Rexista™ Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
“We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin®. This enables us to accelerate the development and commercialization of our abuse deterrent Rexista™ Oxycodone XR product candidate without the need for costly and time-consuming Phase III efficacy trials,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. “We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction.”
Rexista™ Oxycodone XR
Rexista™ Oxycodone XR is the Company’s non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required. The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently or intentionally co-administered with alcohol. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting or snorting.
Intellipharmaceutics Announces Successful Bioequivalence Results for Abuse Deterrent Rexista™ Oxycodone XR
TORONTO, Jan. 14, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone XR (abuse deterrent oxycodone hydrochloride) extended release tablets, dosed under fasted and fed conditions, had demonstrated bioequivalence to Oxycontin® (oxycodone hydrochloride) extended release tablets as manufactured and sold in the United States by Purdue Pharma LP. The study design was based on United States Food and Drug Administration (“FDA”) recommendations and compared the lowest and highest strengths of exhibit batches of the Company’s Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The results show that the ratios of the pharmacokinetic metrics, Cmax, AUC0-t and AUC0-f for Rexista™ vs. Oxycontin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%.
The Company had earlier announced, in March 2015, that topline data results of three definitive Phase I pharmacokinetic clinical trials (single dose fasting, single dose steady-state fasting, and single dose fed), conducted on pilot batches of the Company’s Rexista™ Oxycodone XR, all met the FDA bioequivalence criteria when compared to the existing branded drug Oxycontin®.
The Company had also earlier announced, in May 2015, that the FDA had provided the Company with notification regarding its Investigational New Drug Application (“IND”) submission for Rexista™ Oxycodone XR. The notification from the FDA had stated that the Company would not be required to conduct Phase III studies if bioequivalence to Oxycontin® was demonstrated.
Having now demonstrated such bioequivalence for its Rexista™ Oxycodone XR product to be marketed upon FDA approval, the Company intends to complete the regulatory filing requirements and file a New Drug Application (“NDA”) for Rexista™ Oxycodone XR with the FDA within the next 6 months in accordance with the NDA 505(b)(2) regulatory pathway. There can be no assurance that the FDA will ultimately approve the NDA for the sale of Rexista™ Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
“We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin®. This enables us to accelerate the development and commercialization of our abuse deterrent Rexista™ Oxycodone XR product candidate without the need for costly and time-consuming Phase III efficacy trials,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. “We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction.”
TORONTO, Jan. 14, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone XR (abuse deterrent oxycodone hydrochloride) extended release tablets, dosed under fasted and fed conditions, had demonstrated bioequivalence to Oxycontin® (oxycodone hydrochloride) extended release tablets as manufactured and sold in the United States by Purdue Pharma LP. The study design was based on United States Food and Drug Administration (“FDA”) recommendations and compared the lowest and highest strengths of exhibit batches of the Company’s Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The results show that the ratios of the pharmacokinetic metrics, Cmax, AUC0-t and AUC0-f for Rexista™ vs. Oxycontin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%.
The Company had earlier announced, in March 2015, that topline data results of three definitive Phase I pharmacokinetic clinical trials (single dose fasting, single dose steady-state fasting, and single dose fed), conducted on pilot batches of the Company’s Rexista™ Oxycodone XR, all met the FDA bioequivalence criteria when compared to the existing branded drug Oxycontin®.
The Company had also earlier announced, in May 2015, that the FDA had provided the Company with notification regarding its Investigational New Drug Application (“IND”) submission for Rexista™ Oxycodone XR. The notification from the FDA had stated that the Company would not be required to conduct Phase III studies if bioequivalence to Oxycontin® was demonstrated.
Having now demonstrated such bioequivalence for its Rexista™ Oxycodone XR product to be marketed upon FDA approval, the Company intends to complete the regulatory filing requirements and file a New Drug Application (“NDA”) for Rexista™ Oxycodone XR with the FDA within the next 6 months in accordance with the NDA 505(b)(2) regulatory pathway. There can be no assurance that the FDA will ultimately approve the NDA for the sale of Rexista™ Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
“We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin®. This enables us to accelerate the development and commercialization of our abuse deterrent Rexista™ Oxycodone XR product candidate without the need for costly and time-consuming Phase III efficacy trials,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. “We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction.”
Hi,
Produktpipeline: NDA und ANDAs, wo liegt da der Unterschied ? Thanks
Produktpipeline: NDA und ANDAs, wo liegt da der Unterschied ? Thanks
Antwort auf Beitrag Nr.: 51.448.167 von curacanne am 08.01.16 18:44:36Ja ich bin noch mit einem Teil dabei.
Ausgerechnet heute wurde mir die Ausführung bestätigt.
Ich habe die Hälfte abgegeben (4.000 Stück). Die andere Hälfte
will ich noch behalten. Mir dauert das einfach zu lange bis sich etwas tut.
Wenn ich mich richtig entsinne sind das bereits 7 Jahre.
Ich hatte Aktien von "Vasogen", und meine Aktien wurden zwangsweise
umgetauscht in Intellipharmac. zu einem hundsmiserablen Verhältnis.
Das ärgert mich heute noch.
pflicht
Ausgerechnet heute wurde mir die Ausführung bestätigt.
Ich habe die Hälfte abgegeben (4.000 Stück). Die andere Hälfte
will ich noch behalten. Mir dauert das einfach zu lange bis sich etwas tut.
Wenn ich mich richtig entsinne sind das bereits 7 Jahre.
Ich hatte Aktien von "Vasogen", und meine Aktien wurden zwangsweise
umgetauscht in Intellipharmac. zu einem hundsmiserablen Verhältnis.
Das ärgert mich heute noch.
pflicht
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Antwort auf Beitrag Nr.: 51.240.030 von pflicht am 04.12.15 10:50:45noch dabei??
Antwort auf Beitrag Nr.: 51.229.179 von Moneyplus am 03.12.15 08:57:17Ich hoffe schon seit vielen Jahren auf einen guten Kurs.
Es tut sich bei der Firma einfach nichts. Sollte sich in den kommenden Monaten nichts tun,
werfe ich den Krempel raus.
Grüsse
pflicht
Es tut sich bei der Firma einfach nichts. Sollte sich in den kommenden Monaten nichts tun,
werfe ich den Krempel raus.
Grüsse
pflicht
Antwort auf Beitrag Nr.: 51.228.759 von Moneyplus am 03.12.15 07:42:06erledigt, selbst gefunden 
Denke die kommen bald mit einer KE um die Ecke (so 2 - 3 Mio Shares).
Finde ich aber vertretbar (in Anbetracht der Pipeline und der noch sehr überschaubaren Anzahl an Shares) und bin deshalb heute mal mit ner Anfangsposition rein.
Denke die kommen bald mit einer KE um die Ecke (so 2 - 3 Mio Shares).
Finde ich aber vertretbar (in Anbetracht der Pipeline und der noch sehr überschaubaren Anzahl an Shares) und bin deshalb heute mal mit ner Anfangsposition rein.
Weiß einer wieviel Cash die derzeit haben und wie lange das noch reicht (burn rate) ??
Und das Volumen steigt auch ansehnlich.
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