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georgejjl

08/08/20 9:34 PM

#264094 RE: dadbrotheroftwins #264085

dadbrotheroftwins, That all sounds GREAT and consistent with what others have heard

I spoke to Clint for over 1/2 hour. He has changed my mind. He is amazed that so many people speculate on the nature of the special SAS approval. It's rather simple. Anavex cannot market it as it is not an officially approved drug. Clint said ANY DOCTOR who is treating patients that qualify for 2-73 can fill out the proper forms and ask for it to give to their patients. Just keep in touch with the TGA every month. The patients will have to pay for it out of their pocket, end of story.
I also spoke to him for a bit longer, and heard some good things regarding the PDD trial. He said if the response is what they hoped and expect, they would apply for a PA asap.
I also listened and learned that the Rett trial is going great, and because the girls were older, they were extremely pleased with the readouts from the 6 girls, and he fully expects the younger girls to respond much better.




Good luck and GOD bless,
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plexrec

08/08/20 10:11 PM

#264096 RE: dadbrotheroftwins #264085

dad--"I spoke to Clint for over 1/2 hour."--thank you for that report !!!!
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RedShoulder

08/08/20 11:27 PM

#264107 RE: dadbrotheroftwins #264085

I spoke to Clint for over 1/2 hour. He has changed my mind. He is amazed that so many people speculate on the nature of the special SAS approval. It's rather simple. Anavex cannot market it as it is not an officially approved drug. Clint said ANY DOCTOR who is treating patients that qualify for 2-73 can fill out the proper forms and ask for it to give to their patients. Just keep in touch with the TGA every month. The patients will have to pay for it out of their pocket, end of story.

I also spoke to him for a bit longer, and heard some good things regarding the PDD trial. He said if the response is what they hoped and expect, they would apply for a PA asap.

I also listened and learned that the Rett trial is going great, and because the girls were older, they were extremely pleased with the readouts from the 6 girls, and he fully expects the younger girls to respond much better.


Thanks dadbrotheroftwins for posting your conversation with Clint. I spoke with him also a few hours after the CC to find out if the TGA SAS Part B applied to any physician treating AD patients, and he said that they could receive the drug, but he said that Anavex can't put that out in a PR after I suggested clarification would be helpful.

Your confirming what I heard, but you got positive comments on the PDD and Rett trials is very encouraging - many thanks
dadbrotheroftwins for the pass along.
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jimmy_mcyoloswag

08/09/20 6:26 AM

#264128 RE: dadbrotheroftwins #264085

Thanks for the update!

Can you give more details on the good things you heard on the PDD trial?
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anders2211

08/10/20 7:39 AM

#264287 RE: dadbrotheroftwins #264085

Thank you for your update!

As I have been saying all along just reading the TGA website...

thank you for the reassuring feedback. Im convinded with my anavex investment
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poguemahone

08/10/20 7:56 AM

#264290 RE: dadbrotheroftwins #264085

Based upon your discussion with Clint, perhaps he should be more involved with the CCs, since I got more from your paragraph summary of your phone conversation with him than I did from Missling’s listless half hour.

That is a concern, to say the least.