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Biotech / Medical : ADVR and ONLY ADVR

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To: RickV who wrote (183)	10/27/2000 11:16:40 AM
From: DAN LITTLE	Read Replies (2) of 278

Hi Rick, I thought I would try and give three points of view on when we might see the IND filed. Just for the fun of it. THE OPTIMIST: Globomax is an excellent company with an excellent track record and is guiding ADVR through the FDA process. ADVR will soon be having a pre-IND meeting with the FDA. The maximum amount of time it takes for the FDA to schedule a meeting after receiving the meeting request is 74 days. optimistically speaking, it should take about half that time (37 days). ADVR is undoubtedly within 14 days of requesting the pre-IND meeting. After the meeting there will be very little that needs to be done, given Globalmax's guidance. The IND will need some finishing touches and we do have the holidays coming up (BTW happy holidays in advance). This should put the filing date no later then the 1st of January. The first IND will be for the topical application of product R. Also, love what you've done with your hair. THE REALIST: Globomax is certainly a good company with a good track record. ADVR will request a pre-IND meeting as soon as the agenda is finalized. The FDA should be able to schedule a pre-IND meeting within 45 days of receiving the request. ADVR is probably within 30 days of requesting the pre-IND meeting. There will be a few minor changes that the FDA will want, but should take no longer then three weeks for ADVR to comply. ADVR should file for the IND no later then the 10th of February. The first IND will be for the topical application of Product R according to Mr Gallentar. THE PESSIMIST: Globomax is entitled to a mistake or two just like everyone else. They are bound to overlook something. When ADVR gets around to requesting a pre-IND meeting the FDA won't get it scheduled for at least 60 days. Whatever Globomax has overlooked will take 3 months or longer to correct. There are still inspections to do and a lawsuit to deal with. ADVR will be lucky to submit an IND application by June 1st. We don't know what the first IND will be for, despite what Allen has said. Your haircut sucks. I am going with number 2 with a little bit of number 1 thrown in (nice haircut). Dan

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