Ovascience [NASDAQ:OVAS]
- Creatore Discussione MvArrow
- Data di inizio
Ahahaha anche perchè prima dovranno ricoprirsi pure loro, secondo me qualche altra notizia così, unita a una trimestrale non malvagia e il titolo dovrebbe ripartire!
Ma che voi sappiate come mai AUGMENT non è disponibile negli USA? Motivi etici/religiosi oppure è la FDA che non glielo ha ancora approvato?
Ma che voi sappiate come mai AUGMENT non è disponibile negli USA? Motivi etici/religiosi oppure è la FDA che non glielo ha ancora approvato?
Toponzor
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Non hanno il vaticano in usa, non è un problema religioso.
FDA Concerns Cause OvaScience To Halt U.S. Trial Of Souped-Up IVF Procedure | Xconomy
La FDA voleva che cambiassero designazione alla terapia, da hct/p ( Prodotto da tessuto cellulare umano) a farmaco.
E questo avrebbe comportato anni di test solo per l'approvazione.
Allora hanno deciso di spostare i test all'estero.
Poi non so come e se si è conclusa la questione.
FDA Concerns Cause OvaScience To Halt U.S. Trial Of Souped-Up IVF Procedure | Xconomy
11 Settembre 2013 ha scritto:
La FDA voleva che cambiassero designazione alla terapia, da hct/p ( Prodotto da tessuto cellulare umano) a farmaco.
E questo avrebbe comportato anni di test solo per l'approvazione.
Allora hanno deciso di spostare i test all'estero.
Poi non so come e se si è conclusa la questione.
E' dispiaciuto anche a me, ma se ci si pensa bene alla fine la notizia non era più di tanto eclatante
Ora aspettiamo trimestrali e co.
Certo che se riuscissero a concludere positivamente i test e a farsi approvare dalla FDA la vedremmo volare, ma ci vorrà ancora qualche anno
priz71
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E' dispiaciuto anche a me, ma se ci si pensa bene alla fine la notizia non era più di tanto eclatante
Ora aspettiamo trimestrali e co.
Certo che se riuscissero a concludere positivamente i test e a farsi approvare dalla FDA la vedremmo volare, ma ci vorrà ancora qualche anno
E partire senza il mercato usa è proprio impossibile?Magari quello puo' arrivare dopo visto che i tempi sono lunghi.In che paesi stanno cercando di "entrare" come mercato,si sa?Stanno facendo test dove?Quini di loro prodotti non sono in vendita da nessuna parte al momento,impossibile a questo punto migliorare di parecchio i conti,oppure ho detto una cavolata?
priz71
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Si certo comunque seconda metà 2015 ci siam
ggi tutto saliva è rimasta ferma.Staranno accumulando?Io ho messo stop loss a 27, non vorrei mi facesse qualche scherzetto, secondo me domani va giù, lo ha fatto parecchie volte dopo giornate come quella di oggi, è puro e semplice intuito non spportato da nessuna analisi
Ovviamente se succedesse rientrerei più basso
Ovviamente se succedesse rientrerei più basso
priz71
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Uscita questa news,commenti?il mercato non si fida dei dati usciti,non sembrano affidabili!!
Clinical data may not win over OvaScience skeptics — but revenue will
Jun 17, 2015, 12:11pm EDT
Don Seiffert
Boston Business Journal
For the second time in three months, OvaScience, a Cambridge company aiming to develop a better approach to in vitro fertilization, released new data today that seems to show its method works significantly better than the standard IVF treatments.
And for the second time in three months, the company’s stock dropped immediately following the results.
Today’s data was presented at a European conference, coming from the third of five international sites where the Augment treatment invented by OvaScience (Nasdaq: OVAS) is being offered. It’s the first data from the clinic in the United Arab Emirates, and comes less than three months after results from clinics in Toronto, Ontario and Turkey first emerged. The 59 patients in this dataset are older and had previously gone through more failed IVF treatments on average than the women in the earlier reports from the company.
The head of the UAE site — Dr. Michael Fakih of Fakih IVF — said that 59 women at his clinic with an average age of 37 years underwent the Augment treatment. The women had an average of 4.3 previous IVF cycles each, and those cycles resulted in an average pregnancy rate of 4 percent. With the Augment treatment, the pregnancy rate jumped to 22 percent. Fakih called the data “convincing evidence of the benefit of the Augment treatment.”
In morning trading today, OvaScience shares were down 5 percent to $36.88 as of noon. So what gives?
The reaction is similar to what happened after the Cambridge biotech firm gave results from two different sites (in Toronto, Ontario, and Turkey) on March 30. The pregnancy rate at the Toronto site was found to be 35 percent among the 26 woman who underwent the Augment treatment, and in Turkey was 25 percent in eight women who received the treatment. Those results were met with a 37 percent selloff over the next week, although a faulty initial analysis and a small overall sample size may have contributed to that drop.
The reaction is puzzling, to say the least, for a company that saw the biggest gains of any biotech in Massachusetts in 2014. They run contrary to the fairly positive comments by analysts from H.C. Wainwright and Leerink Partners.
At base, the skepticism that haunts OvaScience is due to the fact that it’s not running controlled trials the same way biotechs developing a drug would. One could argue that since the dates at which patient samples are analyzed seem arbitrary, rather than at pre-determined intervals, the company could wait until the results look positive before deciding to put out a press release. And since there's no specific placebo-control group, it’s trickier to weigh the meaning of a 22 percent (or 35 percent or 25 percent) success rate. A Google search for IVF success rates brings you to a website for t he National Institutes of Health stating the approximate chance of giving birth to a live baby after regular IVF is 33-36 percent for women ages 35-37 and 23-27 percent for women ages 38-40. Those numbers could suggest that the 4 percent pregnancy rate reported among the patients at the UAE clinic might be abnormally low.
The fact is, OvaScience is specifically targeting those patients who've had had a tougher time than most getting pregnant. The 59 women in the patient sample announced today underwent from two and 13 prior IVF cycles each, and that 4 percent pregnancy rate reflects a tougher-to-treat population than any of the patients included in prior reports. Also, today’s data more than doubles the overall sample size to 93 — a respectable cross-section of patients which is only going to increase in coming months as more women undergo the treatment.
In a research note this morning, Leerink partners analyst Paul Matteis reiterated his view that the data so far seem encouraging, and maintained a price target of $48 a share. However, he acknowledged that the results are “unlikely to change the opinion of skeptics who believe that controlled data will be necessary to confirm Augment’s effect and drive uptake.” He believes that where clinical evidence may not succeed in convincing skeptics in coming few months, cold, hard cash (in the form of revenues) will.
“We expect commercial execution, on both 2015 guidance and successful expansion into the UK/Japan and other territories, to be of primary investor focus as the OVAS story evolves over the next 12 months,” he wrote.
Clinical data may not win over OvaScience skeptics — but revenue will
Jun 17, 2015, 12:11pm EDT
Don Seiffert
Boston Business Journal
For the second time in three months, OvaScience, a Cambridge company aiming to develop a better approach to in vitro fertilization, released new data today that seems to show its method works significantly better than the standard IVF treatments.
And for the second time in three months, the company’s stock dropped immediately following the results.
Today’s data was presented at a European conference, coming from the third of five international sites where the Augment treatment invented by OvaScience (Nasdaq: OVAS) is being offered. It’s the first data from the clinic in the United Arab Emirates, and comes less than three months after results from clinics in Toronto, Ontario and Turkey first emerged. The 59 patients in this dataset are older and had previously gone through more failed IVF treatments on average than the women in the earlier reports from the company.
The head of the UAE site — Dr. Michael Fakih of Fakih IVF — said that 59 women at his clinic with an average age of 37 years underwent the Augment treatment. The women had an average of 4.3 previous IVF cycles each, and those cycles resulted in an average pregnancy rate of 4 percent. With the Augment treatment, the pregnancy rate jumped to 22 percent. Fakih called the data “convincing evidence of the benefit of the Augment treatment.”
In morning trading today, OvaScience shares were down 5 percent to $36.88 as of noon. So what gives?
The reaction is similar to what happened after the Cambridge biotech firm gave results from two different sites (in Toronto, Ontario, and Turkey) on March 30. The pregnancy rate at the Toronto site was found to be 35 percent among the 26 woman who underwent the Augment treatment, and in Turkey was 25 percent in eight women who received the treatment. Those results were met with a 37 percent selloff over the next week, although a faulty initial analysis and a small overall sample size may have contributed to that drop.
The reaction is puzzling, to say the least, for a company that saw the biggest gains of any biotech in Massachusetts in 2014. They run contrary to the fairly positive comments by analysts from H.C. Wainwright and Leerink Partners.
At base, the skepticism that haunts OvaScience is due to the fact that it’s not running controlled trials the same way biotechs developing a drug would. One could argue that since the dates at which patient samples are analyzed seem arbitrary, rather than at pre-determined intervals, the company could wait until the results look positive before deciding to put out a press release. And since there's no specific placebo-control group, it’s trickier to weigh the meaning of a 22 percent (or 35 percent or 25 percent) success rate. A Google search for IVF success rates brings you to a website for t he National Institutes of Health stating the approximate chance of giving birth to a live baby after regular IVF is 33-36 percent for women ages 35-37 and 23-27 percent for women ages 38-40. Those numbers could suggest that the 4 percent pregnancy rate reported among the patients at the UAE clinic might be abnormally low.
The fact is, OvaScience is specifically targeting those patients who've had had a tougher time than most getting pregnant. The 59 women in the patient sample announced today underwent from two and 13 prior IVF cycles each, and that 4 percent pregnancy rate reflects a tougher-to-treat population than any of the patients included in prior reports. Also, today’s data more than doubles the overall sample size to 93 — a respectable cross-section of patients which is only going to increase in coming months as more women undergo the treatment.
In a research note this morning, Leerink partners analyst Paul Matteis reiterated his view that the data so far seem encouraging, and maintained a price target of $48 a share. However, he acknowledged that the results are “unlikely to change the opinion of skeptics who believe that controlled data will be necessary to confirm Augment’s effect and drive uptake.” He believes that where clinical evidence may not succeed in convincing skeptics in coming few months, cold, hard cash (in the form of revenues) will.
“We expect commercial execution, on both 2015 guidance and successful expansion into the UK/Japan and other territories, to be of primary investor focus as the OVAS story evolves over the next 12 months,” he wrote.
dave4trade
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Pronti al botto?
lamponuovo
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Condivido... dopo la pubblicazione di questo articolo e con la massa di posizioni short esistenti... può succedere veramente uno short squeeze impressionante.
http://www.ovascience.com/files/JFIV_Fakih_et_al_The_AUGMENT_Experience_Aug_2015.pdf
Motivo per cui ho fatto una puntatina... per il momento puramente speculativa