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Biotech / Medical : ADVR and ONLY ADVR -- Ignore unavailable to you. Want to Upgrade?

To: Bernie Bildman who wrote (31)	9/23/2000 6:53:28 PM
From: DAN LITTLE	Respond to of 278

There is a lot of information available on Pre-IND meetings with the FDA. Here is a good url fda.gov Simply type in Pre-IND and you will have more then enough information. For convenience I posted the information below. It gives a good brief heads up, but it appears that the FDA will even go as far as helping a company fill out the IND forms. Pre-IND meeting: Prior to the submission of an initial IND, the sponsor may request a meeting with FDA to review and reach agreement on the design of animal studies needed to support human clinical testing. The format for the IND, the scope and design of planned Phase 1 clinical studies, and product characterization issues may also be discussed (see 21 CFR 312.82). Note that a meeting to discuss the general development of a drug may take place without an IND, and would be considered a type C meeting. As a guide: submit a background package that includes the following Pre-IND meeting - a summary of manufacturing information including completed or proposed testing and specifications; any pre-clinical work completed or proposed; and any known experience with the product in humans; the proposed eventual clinical use with rationale; a reasonably complete protocol; and information on any unique characteristics which differentiate the product from other similar entities. Separate meetings for manufacturing, clinical, and/or establishment issues are encouraged, if the proposed agenda includes extensive discussion of more than one of these topics. This will provide for the most efficient use of reviewer time. These meetings should be consecutive but separated by 5 - 10 minutes to allow for non-disruptive exit and entrance of persons attending the meetings. It is expected that the scheduled times would be respected, i.e., additional discussion needed for the earlier meeting subject, should be tabled until another time. Any person scheduled for one of the meetings should have the option of attending all of the meetings. The POC will ensure that a meeting summary is drafted, and finalized. This meeting summary will constitute the official minutes of the meeting. The meeting summary will clearly outline the important agreements reached, any disagreements remaining, issues for further discussion and action items.

To: Bernie Bildman who wrote (31)	9/24/2000 9:28:14 AM
From: DAN LITTLE	Read Replies (1) \| Respond to of 278

I would like to clarify something I reported earlier plus add a little more food for thought. The initial filing of an IND, as I reported earlier, seems to have a failure rate of above 50%. This is because the FDA usually asks for more information. I cannot remember a single one that failed completely (although I'm sure that happens). The request for more information from the FDA will result in a six week or longer (usually longer) delay before the company will refile. Then another 30 days for acceptance from the time the FDA receives it. The FDA may still request even more information and the process starts all over again. The FDA gives out a very thorough filing packet. Most companies probably feel that they can cross all the T's and dot all the I's themselves without going to the extra expense of hiring a Globomax or setting up meetings with the FDA. The extra expense V the extra time. For a start up company I suspect most will do the time. For a company filing an IND with fast track status I would think that a Pre-IND meeting with the FDA would be absolutely essential. We have seen ADVR give projected filing dates only to back off and project one farther down the road. Could it be the results of a Pre-IND meeting that pushed these dates back (seems as likely a possibility as anything else I've heard or thought of)? When you think about the time it would save, in the long run, to file an IND with fast track as opposed to getting fast track later or none at all. The time spent ironing out the problems ahead of the IND will probably save 2-3 years in the overall FDA process. Dan PS. Lost power here yesterday afternoon and I had some really good links too. I'll try and dig up one or two again.

To: Bernie Bildman who wrote (31)	9/24/2000 5:39:45 PM
From: DAN LITTLE	Read Replies (1) \| Respond to of 278

For fast track guidance from the FDA, see URL below. This is good stuff Bernie. I cannot see any reason why Product R would not be fast tracked. It certainly fits within the guidelines, as near as I can tell. What do you think? This also shows that the FDA seems more then willing to work with a company that is Filing for a fast track IND. There are also other programs that CDER offers that should help a company ease through the FDA process. I have to say that I think ADVR is taking advantage of them. Globomax knows the ropes and like you said even has some past FDA employees working for them. fda.gov Here is a small section of the above document: A. Meetings Appropriately timed meetings between the regulated industry and FDA are a critical aspect of efficient drug development. Sponsors of products in fast track drug development programs should be in regular contact with the appropriate reviewing division to ensure that the evidence necessary to support marketing approval will be developed and presented in a format conducive to an efficient review. Specifically, the following are strongly recommended: 1. Pre-IND consultation so that (i) appropriate preclinical studies can be performed to demonstrate the potential to address unmet medical needs and to support introduction of the product into human trials, (ii) phase 1 studies can be optimally designed to support further product development, (iii) overall development strategy can be considered, and (iv) issues regarding the potential for fast track designation may be discussed. HERE ARE SOME ADDITIONAL SITES CDER site (FDA guidance page). CDER is a great overall site fda.gov This one came from the site above. IND guidance and filing requirements.This is in PDF format. fda.gov Keep up with AIDS, and other, trials actis.org centerwatch.com clinicaltrials.gov Huge medical data base www-sci.lib.uci.edu