It was a positive 3rd quarter conference call from ACAD after hours today. The main points to consider are listed below.
A) The company will start a phase 2 Alzheimer's trial in November with Pimavanserin for patients with (ADP) Alzheimer's Disease Psychosis.
B) Three month stability testing has been completed in October. Typically the FDA would like to see 12 month stability testing when submitting a new drug application. Perhaps they can submit while continuing additional stability testing in progress.
C) They will have 75 sales representatives in the US to sell Pimavanserin for PDP, and more than likely partner outside of U.S.
D) Regarding the EU approval process for PDP. ACAD will talk with the EU in the fall of 2013.
E) Currently 200 patients have been taking Pima for over one year, and 100 patients over two years. The longest patient has been taking Pima for eight years. More proof of solid safety data that Pimavanserin offers that other atypical drugs do not.
Bottom Line: ACAD is doing everything right by preparing to start the Alzheimer's phase 2 trial in November, and at the same time is readying data for FDA approval for PDP by the end of 2014. The stock has come down considerably making the price today a good area to start a position. Thank you for reading.
A) The company will start a phase 2 Alzheimer's trial in November with Pimavanserin for patients with (ADP) Alzheimer's Disease Psychosis.
B) Three month stability testing has been completed in October. Typically the FDA would like to see 12 month stability testing when submitting a new drug application. Perhaps they can submit while continuing additional stability testing in progress.
C) They will have 75 sales representatives in the US to sell Pimavanserin for PDP, and more than likely partner outside of U.S.
D) Regarding the EU approval process for PDP. ACAD will talk with the EU in the fall of 2013.
E) Currently 200 patients have been taking Pima for over one year, and 100 patients over two years. The longest patient has been taking Pima for eight years. More proof of solid safety data that Pimavanserin offers that other atypical drugs do not.
Bottom Line: ACAD is doing everything right by preparing to start the Alzheimer's phase 2 trial in November, and at the same time is readying data for FDA approval for PDP by the end of 2014. The stock has come down considerably making the price today a good area to start a position. Thank you for reading.
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