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Posted On: 06/17/2017 2:07:35 PM
Post# of 22813
Hey Fitz,, not sure if you ever noticed but Anita J. Chawla, Phd. Sits on the Board of Directors for CYTR. I wonder if she is married to Sant Chawla, Chief Investigator for CYTR's Aldoxorubocin study?
I imagine the information being presented to the FDA will be the same which was provided at the 2017 ASCO annual meeting.
Also, there was a stockholders meeting last Wednesday.
This was shown on the web-site: (not sure why they are listed on the link I found to be submitting data in the next couple of weeks)
In March 2017, CytRx met with the U.S. FDA to discuss a regulatory strategy for submitting an New Drug Application or NDA for aldoxorubicin. CytRx and the FDA agreed that the aldoxorubicin NDA submission will be under the 505(b)(2) regulatory pathway. The FDA has not requested additional clinical trials prior to submitting the NDA. CytRx’s goal is to initiate a rolling NDA in Q4 2017.
I imagine the information being presented to the FDA will be the same which was provided at the 2017 ASCO annual meeting.
Also, there was a stockholders meeting last Wednesday.
This was shown on the web-site: (not sure why they are listed on the link I found to be submitting data in the next couple of weeks)
In March 2017, CytRx met with the U.S. FDA to discuss a regulatory strategy for submitting an New Drug Application or NDA for aldoxorubicin. CytRx and the FDA agreed that the aldoxorubicin NDA submission will be under the 505(b)(2) regulatory pathway. The FDA has not requested additional clinical trials prior to submitting the NDA. CytRx’s goal is to initiate a rolling NDA in Q4 2017.
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
https://twitter.com/twitter/statuses/957208055766241280
https://twitter.com/twitter/statuses/957208055766241280
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