updates on pagoclone

[Jcows]

Ok guys I emailed Dr. Gerald Maguire a couple days ago regarding the update on the status on the pagoclone trials. He returned my email saying:

Thank you for contacting me. The pagoclone Phase IIb study is ongoing
and all subjects for this phase have been enrolled. The study is
currently being conducted with subjects in the double-blind phase and
the data will not be analyzed until all subjects have completed the
double-blind portion and the data have been locked per FDA requirements.

If you need further info, let me know.

Take care,

Jerry

-----

I then asked him- if all goes well, when could we see this drug released?
and he responded:


Wow, Jordan--I wish I could predict the FDA future! No one has ever submitted a medication to the FDA for approval in stuttering so this could mean a fast-track to approval as there is such a medical need. I suggest you contact the folks at Endo Pharmaceuticals or Teva Pharmaceuticals to receive the official speculation.

All the best,

Jerry

---

I will contact Endo and Teva pharmaceuticals and post their feedback on the forum. Judging from the second email, "this could mean a fast-track to approval as there is such a medical need", it looks like...we could be seeing it sometime next year.

[urbanmermaid]

Thanks so much for this update! :)

Does anyone know when this phase ends? They'd need extra time after that for analysing the data, getting the FDA approval, etc...

[JFan]

I'm in the study, and I believe it ends in December of 2009.

[Jaykon]

Ok guys I emailed Dr. Gerald Maguire a couple days ago regarding the update on the status on the pagoclone trials. He returned my email saying:

Thank you for contacting me. The pagoclone Phase IIb study is ongoing
and all subjects for this phase have been enrolled. The study is
currently being conducted with subjects in the double-blind phase and
the data will not be analyzed until all subjects have completed the
double-blind portion and the data have been locked per FDA requirements.

If you need further info, let me know.

Take care,

Jerry

-----

I then asked him- if all goes well, when could we see this drug released?
and he responded:


Wow, Jordan--I wish I could predict the FDA future! No one has ever submitted a medication to the FDA for approval in stuttering so this could mean a fast-track to approval as there is such a medical need. I suggest you contact the folks at Endo Pharmaceuticals or Teva Pharmaceuticals to receive the official speculation.

All the best,

Jerry

---

I will contact Endo and Teva pharmaceuticals and post their feedback on the forum. Judging from the second email, "this could mean a fast-track to approval as there is such a medical need", it looks like...we could be seeing it sometime next year.


crossed fingerz dood!

[vishvas]

Did anyone contacted Endo or Teva Pharmaceuticals when we would see the Pagoclone released?