Ann: ATL1102 for Multiple Sclerosis Phase IIb trial Update, page-9

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itsagas

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27/07/17

20:56

Post #: 26125983
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Originally posted by itsagas ↑

In my opinion a good announcement.
I wrote multiple posts re Innate and them not going to the FDA for a trial design for IND..History proves I was correct.
ANP have been in talks with the FDA in regard to Atl 1102 for MS and have been told by the FDA that modifications to the proposed clinical trial are needed..That's why it's important for any IND application to go to the FDA for the Trial design.
I knew that the FDA approval was tied in with the Non dilutive funding and the MS funding for the small study in Germany....THe clinical modifications are of great benefit to ANP .Remember most Biotechs are partnered in phase 2b and using all the resources of a big PHARMA.
SO good work ANP staff for getting the application to the FDA.We should have the IND approved by end of Sept 2017.
Have to be in ANPOB options for a year..for the tax benefit so a couple of months don't matter..

THe application for Non dilutive funding is also good news with the ANP synopsis for the P2b study passing 2 levels of feasibility assessment.Like I said the FDA modifications will help giving our application more credibility..

THe DMD trial at the RCH in Melbourne is ongoing...ANP is addressing the questions in line with the hospitals approval process...if one looks up the Ethics timetable the next meeting is on the 7/August/ 2017...Lets hope we get the green light then....

ALl in All ITSA is HAPPY...IT WILL BE WORTH THE WAIT...

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Sorry People.i made a mistake...AEI insist that Approval for DMD is end of Sept 2017.
For some reason I thought" by Sept."
The HREC meeting date is the 4/sept/ 2017.(Ethics ).since it's the last meeting before the end of Sept..Lets hope we get the green light then.

THe fact that ANP is still continuing with the Non diluting fund application is a good sign that the Clinical hold re IND trial design can be modified to get the FDA clearance.Let's hope.

ANP Price at posting: 3.9¢ Sentiment: Buy Disclosure: Held
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