Thursday, April 24, 2014 4:52:08 PM
It is very common during FDA’s review process to ask for clarification of some aspects of the submission. As you can see, the companies have not received any rejections...If it was not an approvable form, the FDA would have issued another CRL...This is a very good sign FDA considers IGXT and Redhill resubmission as an approvable form and as it common in the process to request follow up clarification.
To clarify even more, it is also common that if the resubmission is an approvable form, and as we can see it was evident this was a class 1 resubmission, becasue as for the FDA to find in the resubmission what else they needed to be clarified from the companies, they would have to have had a thorough review. Don't you think?
Once FDA questions have been clarified, FDA will issue a decision. I have seen this happen with many pharmas, and it is usually within weeks after the company’s providing their response.
GLTA
Recent IGXT News
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/14/2024 07:45:06 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/23/2024 08:00:40 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 07/15/2024 04:15:15 AM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 07/08/2024 09:23:06 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 07/08/2024 09:18:26 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 07/08/2024 06:50:04 PM
Element79 Gold Corp Appoints Warren Levy to Board of Directors • ELMGF • Aug 28, 2024 9:51 AM
Integrated Ventures Announces Strategic Entry Into Health & Wellness Industry with Focus on GLP-1 Products • INTV • Aug 28, 2024 8:30 AM
ELEMENT79 ANNOUNCES UPLISTING TO OTCQB VENTURE MARKET • ELMGF • Aug 26, 2024 10:03 AM
North Bay Resources Announces Gold Assays up to 2.2 Ounces per Ton, Fran Gold Project, British Columbia • NBRI • Aug 26, 2024 10:00 AM
PickleJar Unveils Latest Venue Managed Services Innovations in Upcoming Webinar • PKLE • Aug 23, 2024 1:11 PM
Element79 Gold Corp Provides Update on Nevada Portfolio • ELMGF • Aug 23, 2024 8:00 AM